510(k) K051025 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
| Applicant | Hologic, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, May 13, 2005 |
| Received | Apr 22, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051025
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2013 | Hologic, Inc. Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x
The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patien Terminated |
JAA | None listed |
| May 17, 2013 | Hologic, Inc. Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2
The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization o Terminated |
JAA | None listed |
| Sep 25, 2012 | Hologic, Inc. Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1
The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic vis Terminated |
JAA | None listed |
| Sep 25, 2012 | Hologic, Inc. Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2
The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic v Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.