K033870 is an FDA 510(k) clearance for the IMAGE MANAGEMENT SYSTEM. This device is classified as a Colposcope (and Colpomicroscope) (Class II - Special Controls, product code HEX).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on March 12, 2004, 91 days after receiving the submission on December 12, 2003.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1630.
| 510(k) Number | K033870 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2003 |
| Decision Date | March 12, 2004 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEX — Colposcope (and Colpomicroscope) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1630 |