K233699 is an FDA 510(k) clearance for the SubtleREFORMAT (1.x). This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Subtle Medical, Inc. (Menlo Park, US). The FDA issued a Cleared decision on April 29, 2024, 164 days after receiving the submission on November 17, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K233699 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2023 |
| Decision Date | April 29, 2024 |
| Days to Decision | 164 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 |