K223484 is an FDA 510(k) clearance for the IGAR System (1001.A). This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Insight Medbotics, Inc. (Hamilton, CA). The FDA issued a Cleared decision on July 20, 2023, 244 days after receiving the submission on November 18, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K223484 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2022 |
| Decision Date | July 20, 2023 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MOS - Coil, Magnetic Resonance, Specialty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |