Data / Medical devices / United States / Del Medical, Inc.
Del Medical, Inc.: FDA-registered device maker in Bloomingdale, IL, United States, 6 510(k) clearances
Del Medical, Inc. is registered with the FDA (registration 1418964) in Bloomingdale, IL, United States. It lists 15 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 10, 2023. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1418964
- Address
- 241 Covington Dr, Bloomingdale, IL, United States, 60108
- Owner or operator
- Del Medical, Inc (10031137)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- December 23, 2009
- Registered through
- 2026
- Brand names listed
- AL02, Anesthesia Screen Holder Assembly, Anthem 30-400, Anthem 32-500, Anthem 40-500, Anthem 40-600, Anthem 50-650, Assembly Tube and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 10, 2023 | K223550 | DMX | KPR | Substantially Equivalent | Del Medical, Inc. | accessdata.fda.gov |
| November 20, 2017 | K173018 | MDR17 Mobile Direct Radiographic System | IZL | Substantially Equivalent | Del Medical, Inc. | accessdata.fda.gov |
| July 17, 2014 | K140825 | DELWORKS DR SYSTEM | MQB | Substantially Equivalent | Del Medical, Inc. | accessdata.fda.gov |
| July 11, 2012 | K121838 | LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM | MQB | Substantially Equivalent | Liebel-Flarsheim | accessdata.fda.gov |
| July 14, 2009 | K091517 | RALCO, MODEL R225 ACS | IZW | Substantially Equivalent | Ralco S.R.L. | accessdata.fda.gov |
| April 6, 2007 | K070796 | CHILI PACS | LLZ | Substantially Equivalent | Chili GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 3, 2015 | 72798 | Class II | Terminated | 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. | accessdata.fda.gov |
| January 12, 2009 | 50841 | Not yet classified | Terminated | 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 M | 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. | accessdata.fda.gov |
| October 3, 2006 | 36478 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
| March 10, 2005 | 31456 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
| February 13, 2004 | 28372 | Not yet classified | Terminated | 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 | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Collimator, Manual, Radiographic
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of Screen, Leaded, Operator Radiation Protector
- All makers of System, X-Ray, Stationary
- All makers of System, X-Ray, Mobile
- All makers of Holder, Radiographic Cassette, Wall-Mounted
Updated April 10, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.