K212004 is an FDA 510(k) clearance for the MyoSPECT, MyoSpect ES. This device is classified as a System, Tomography, Computed, Emission (Class II - Special Controls, product code KPS).
Submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on August 27, 2021, 60 days after receiving the submission on June 28, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200.
| 510(k) Number | K212004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2021 |
| Decision Date | August 27, 2021 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPS — System, Tomography, Computed, Emission |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1200 |