K141657 is an FDA 510(k) clearance for the THD REVOLUTION. This device is classified as a Monitor, Ultrasonic, Nonfetal (Class II - Special Controls, product code JAF).
Submitted by Thd Spa (Imola, Bo, IT). The FDA issued a Cleared decision on February 24, 2015, 249 days after receiving the submission on June 20, 2014.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1540.
| 510(k) Number | K141657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2014 |
| Decision Date | February 24, 2015 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAF - Monitor, Ultrasonic, Nonfetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1540 |