K982952 is an FDA 510(k) clearance for the IMFAST. This device is classified as a System, Radiation Therapy, Charged-particle, Medical (Class II - Special Controls, product code LHN).
Submitted by Siemens Medical Solutions USA, Inc. (Concord, US). The FDA issued a Cleared decision on March 5, 1999, 193 days after receiving the submission on August 24, 1998.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K982952 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1998 |
| Decision Date | March 05, 1999 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LHN — System, Radiation Therapy, Charged-particle, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |