K191544 is an FDA 510(k) clearance for the Synapse 3D Blood Flow Analysis. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Fujifilm Corporation (Minato-Ku, Tokyo, JP). The FDA issued a Cleared decision on October 18, 2019, 129 days after receiving the submission on June 11, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K191544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2019 |
| Decision Date | October 18, 2019 |
| Days to Decision | 129 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 |