K011604 is an FDA 510(k) clearance for the PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI. This device is classified as a System, Nuclear Magnetic Resonance Spectroscopic (Class II - Special Controls, product code LNI).
Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on August 22, 2001, 90 days after receiving the submission on May 24, 2001.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K011604 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2001 |
| Decision Date | August 22, 2001 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LNI - System, Nuclear Magnetic Resonance Spectroscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |