K191539 is an FDA 510(k) clearance for the 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Rapid Biomedical GmbH (Rimpar, DE). The FDA issued a Cleared decision on January 31, 2020, 235 days after receiving the submission on June 10, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K191539 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2019 |
| Decision Date | January 31, 2020 |
| Days to Decision | 235 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 |