K172216 is an FDA 510(k) clearance for the ACIST RXi Mini System. This device is classified as a Amplifier And Signal Conditioner, Transducer Signal (Class II - Special Controls, product code DRQ).
Submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 18, 2017, 25 days after receiving the submission on July 24, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2060.
| 510(k) Number | K172216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2017 |
| Decision Date | August 18, 2017 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRQ — Amplifier And Signal Conditioner, Transducer Signal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2060 |