Sedecal S.A.
ALGETE Madrid, ES
SEDECAL S.A. appears in FDA device records in ALGETE Madrid, ES. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 57 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for Sedecal S.A. between 2002 and 2023. The busiest year on record is 2009, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2004 | 2 |
| 2006 | 2 |
| 2009 | 3 |
| 2011 | 3 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232185 | SM-IV | IZL | Substantially Equivalent | |
| K222951 | SM-V | IZL | Substantially Equivalent | |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | IZL | Substantially Equivalent | |
| K212291 | PHOENIX | IZL | Substantially Equivalent | |
| K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems | KPR | Substantially Equivalent | |
| K202293 | Radiographic System Challenge X | KPR | Substantially Equivalent | |
| K192936 | Soltus 500 | IZL | Substantially Equivalent | |
| K192011 | PhoeniX | IZL | Substantially Equivalent | |
| K191813 | MobileDiagnost wDR 2.2 | IZL | Substantially Equivalent | |
| K173299 | DRAGON X SPSL4HC, DRAGON X SPSL8HC | IZL | Substantially Equivalent | |
| K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR | IZL | Substantially Equivalent | |
| K141895 | MOBILEDIAGNOST WDR | IZL | Substantially Equivalent | |
| K133782 | NOVA FA DR SYSTEM | MQB | Substantially Equivalent | |
| K130883 | SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T | MQB | Substantially Equivalent | |
| K121410 | DRAGON LW | IZL | Substantially Equivalent | |
| K101517 | SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY | IZL | Substantially Equivalent | |
| K111725 | MOBILEDIAGNOST WDR | IZL | Substantially Equivalent | |
| K103522 | SEDECAL | IZL | Substantially Equivalent | |
| K090322 | EASY MOVING PLUS, SM-XXHF-YY | IZL | Substantially Equivalent | |
| K090279 | SEDECAL, MILLENNIUM PLUS | KPR | Substantially Equivalent | |
| K090238 | SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS | KPR | Substantially Equivalent | |
| K063283 | DEFINIUM 5000 X-RAY SYSTEM | MQB | Substantially Equivalent | |
| K062335 | SEDECAL X PLUS LP PLUS | KPR | Substantially Equivalent | |
| K043002 | SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR | IZL | Substantially Equivalent | |
| K042876 | URS LP DIGITAL, MILLENNIUM, RADPRO | KPR | Substantially Equivalent | |
| K020436 | PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 | IZL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9617251 | 3002495042 | SEDECAL S.A. | PELAYA, 9, ALGETE Madrid(Province) 28110 ES | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- IXYHolder, Radiographic Cassette, Wall-Mounted
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- IZZTable, Radiographic, Non-Tilting, Powered
- IXQTable, Radiographic, Stationary Top
- KXJTable, Radiologic
- IYBTube Mount, X-Ray, Diagnostic
Recall records
Showing 25 of 57| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0287-2026 | SM_40HF_BDC3, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0286-2026 | SM_40HF_BDC, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0285-2026 | SM_40HF_B_D_VIR3.004, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0284-2026 | SM_40HF_B_D_VIR3, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0283-2026 | SHIMADZU RF.004, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0282-2026 | SED URS LP, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0281-2026 | RADPRO MOBILE, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0280-2026 | Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0279-2026 | Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0278-2026 | Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0277-2026 | Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0276-2026 | Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0275-2026 | Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0274-2026 | Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0273-2026 | Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0272-2026 | Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0271-2026 | Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0270-2026 | Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0269-2026 | Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0268-2026 | Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0267-2026 | Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0266-2026 | Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0265-2026 | Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0264-2026 | Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified | |
| Z-0263-2026 | Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain