K211432 is an FDA 510(k) clearance for the Myomics Q. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Phantomics, Inc. (Seoul, KR). The FDA issued a Cleared decision on November 23, 2021, 200 days after receiving the submission on May 7, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K211432 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2021 |
| Decision Date | November 23, 2021 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |