K950317 is an FDA 510(k) clearance for the ADVANTX 1824 SPOTFILM DEVICE. This device is classified as a Device, Spot-film (Class II - Special Controls, product code IXL).
Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on February 8, 1995, 13 days after receiving the submission on January 26, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1670.
| 510(k) Number | K950317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1995 |
| Decision Date | February 08, 1995 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXL - Device, Spot-film |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1670 |