K042368 is an FDA 510(k) clearance for the PRACTIX CONVENIO. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Philips Medical Systems North America Co. (Bothell, US). The FDA issued a Cleared decision on October 4, 2004, 34 days after receiving the submission on August 31, 2004.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K042368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2004 |
| Decision Date | October 04, 2004 |
| Days to Decision | 34 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZL — System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |