510(k) K121838 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
| Applicant | Liebel-Flarsheim, Cincinnati OH, US |
| Decision | Substantially Equivalent, Jul 11, 2012 |
| Received | Jun 22, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121838
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2021 | LIEBEL-FLARSHEIM COMPANY LLC HydraVision Digital Imaging System
Product ID/Reorder Number: 705559 (65KW) Terminated |
MQB | None listed |
| Feb 27, 2017 | LIEBEL-FLARSHEIM COMPANY LLC Liebel-Flarsheim Direct Digital Imaging System (DDIS)
Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primaril Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.