K091628 is an FDA 510(k) clearance for the OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX. This device is classified as a Processor, Radiographic-film, Automatic (Class II - Special Controls, product code IXW).
Submitted by Protec GmbH & Co. KG (Oberstenfeld, DE). The FDA issued a Cleared decision on August 21, 2009, 78 days after receiving the submission on June 4, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.
| 510(k) Number | K091628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2009 |
| Decision Date | August 21, 2009 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXW — Processor, Radiographic-film, Automatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1900 |