510(k) K953801 ยท KPS System, Tomography, Computed, Emission
VARICAM
| Applicant | Elscint, Inc., Hackensack NJ, US |
| Decision | Substantially Equivalent, Nov 22, 1995 |
| Received | Aug 11, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953801
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System Open, Classified |
KPS | None listed |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers:
1) ASM000085;
2) ASM001092;
3) SYS000001; System, Tomography, Computed, Emission Open, Classified |
KPS | None listed |
| Oct 30, 2017 | GE Healthcare, LLC Discover VH/Millennium VG Nuclear Medicine Imaging System Completed |
KPS | None listed |
| Oct 30, 2017 | GE Healthcare, LLC VariCam Completed |
KPS | None listed |
| Mar 13, 2015 | GE Healthcare GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations.
Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging proce Terminated |
KPS | None listed |
| Jul 24, 2013 | GE Healthcare, LLC GE Healthcare Varicam/VG and VG Hawkeye devices
Product Usage:
The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer upt Terminated |
KPS | None listed |
| Oct 7, 2004 | General Electric Med Systems LLC Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam. Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.