Del Medical, Inc.
Bloomingdale, IL, US
DEL MEDICAL, INC. appears in FDA device records in Bloomingdale, IL. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Del Medical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Del Medical Systems Grouprecall
510(k) clearance history
FDA records hold 4 510(k) clearances for Del Medical, Inc. between 2014 and 2023. The busiest year on record is 2014, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223550 | DMX | KPR | Substantially Equivalent | |
| K173018 | MDR17 Mobile Direct Radiographic System | IZL | Substantially Equivalent | |
| K152767 | OTC12D AUTO RADIOGRAPHIC SYSTEM | KPR | Substantially Equivalent | |
| K140825 | DELWORKS DR SYSTEM | MQB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1418964 | 1418964 | DEL MEDICAL, INC. | 241 Covington Dr, Bloomingdale, IL 60108 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ITYAssembly, Tube Housing, X-Ray, Diagnostic
- IZWCollimator, Automatic, Radiographic
- IZXCollimator, Manual, Radiographic
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- IXJGrid, Radiographic
- IXYHolder, Radiographic Cassette, Wall-Mounted
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- LLZSystem, Image Processing, Radiological
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- KQSTable, Cystometric, Non-Electric And Accessories
- IZZTable, Radiographic, Non-Tilting, Powered
- KXJTable, Radiologic
- IYBTube Mount, X-Ray, Diagnostic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0762-2016 | VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department. | The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient. | Class II | Terminated | |
| Z-0761-2016 | VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department. | The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient. | Class II | Terminated | |
| Z-1247-2009 | Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch or 10 inch Column Extensions; a radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Del Medical Systems Group, 11550 West King Street, Franklin Park, IL 60131-1330. The device is used for X-Ray tube positioning. | There is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator. | Terminated | ||
| Z-0049-2007 | DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King Street, Franklin Park, IL 60131-1330; Phantom model (PH-150-CM & PH-150-G) | The x-ray tube head assembly of the Phantom Portable X-Ray System may detach from the boom arm assembly. The tube head could fall and contact the patient or operator. | Terminated | ||
| Z-0816-05 | Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131 | The Phantom Portable X-Ray System Stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. It the weld fails, the tubehead arm assembly could fall and contact the patient or operator. | Terminated | ||
| Z-0712-04 | DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Manufactured by Del Medical Imaging Corporation, Franklin Park, IL 60131 U.S.A. | There is a potentially defective worm gear in the tension adjusting mechanism of the balancer used in the Digital Ceiling Mounted Tube Support System for overhead x-ray units. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain