Sedecal USA, Inc
Niles, IL, US
SEDECAL USA, INC. appears in FDA device records in Niles, IL. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 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 3 510(k) clearances for Sedecal USA, Inc between 2001 and 2004. The busiest year on record is 2001, with 2. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 2 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042361 | DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D | IZL | Substantially Equivalent | |
| K012546 | OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM | KPR | Substantially Equivalent | |
| K012663 | EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) | IZL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1422346 | 1000139935 | SEDECAL USA, INC. | 7555 N. Caldwel Ave, Niles, IL 60714 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1691-2016 | Sedecal SA Mobile Diagnost w DR x-ray system | Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type " Newborn" was selected and is displayed in the generator control area of the Eleva User Interface. | Class II | Terminated | |
| Z-0001-04 | Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain | A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the SP-HF-4.0 Portable Systems not complying with the U.S. Federal performance standard. | Terminated | ||
| Z-650/51-03 | Easy Moving Motor Driven Mobile X-Ray Unit, Models SM-20HF and SM-30HF; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN | Incorrect identification labels and failure of the cretification testing resulting in noncompliance with the U.S> Federal performance standard | Terminated | ||
| Z-0649-03 | Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN | Incorrect indentification labels and their certification testing program failed in noncompliance with the U.S. Federal performance standard. | Terminated | ||
| Z-0652-03 | Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN | Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain