510(k) K212004 ยท KPS System, Tomography, Computed, Emission
MyoSPECT, MyoSpect ES
| Applicant | GE Healthcare, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Aug 27, 2021 |
| Received | Jun 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212004
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2024 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system). Open, Classified |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.