510(k) K914807 ยท KPS System, Tomography, Computed, Emission
APEX HELIX - A
| Applicant | Elscint, Inc., Hackensack NJ, US |
| Decision | Substantially Equivalent, Feb 27, 1992 |
| Received | Oct 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914807
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2013 | GE Healthcare, LLC Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera
Product Usage:
The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detec Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.