K133848 is an FDA 510(k) clearance for the RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Heartvista, Inc. (Menlo Park, US). The FDA issued a Cleared decision on June 25, 2014, 189 days after receiving the submission on December 18, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K133848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2013 |
| Decision Date | June 25, 2014 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LNH - System, Nuclear Magnetic Resonance Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |