K031597 is an FDA 510(k) clearance for the DUNLEE FORMAT COLLIMATOR FAMILY. This device is classified as a Collimator, Automatic, Radiographic (Class II - Special Controls, product code IZW).
Submitted by Philips Medical Systems North America Co. (Bothell, US). The FDA issued a Cleared decision on July 21, 2003, 61 days after receiving the submission on May 21, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1610.
| 510(k) Number | K031597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2003 |
| Decision Date | July 21, 2003 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZW — Collimator, Automatic, Radiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1610 |