510(k) K943581 ยท IXR Table, Radiographic, Tilting
HYDRADJUST IV UROLOGICAL TABLE
| Applicant | Mallinckrodt Group, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jan 4, 1995 |
| Received | Jul 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943581
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2017 | LIEBEL-FLARSHEIM COMPANY LLC Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR)
Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, prima Terminated |
IXR | None listed |
| Jul 18, 2013 | Leibel-Flarsheim Company LLC Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures. Terminated |
OWB | None listed |
| Jun 25, 2010 | Mallinckrodt Inc Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237.
Facilitates digital radiologic and/or fluoroscop Terminated |
IZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.