K944967 is an FDA 510(k) clearance for the TOMO-LINK. This device is classified as a System, X-ray, Tomographic (Class II - Special Controls, product code IZF).
Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on December 9, 1994, 59 days after receiving the submission on October 11, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1740.
| 510(k) Number | K944967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 1994 |
| Decision Date | December 09, 1994 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZF - System, X-ray, Tomographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1740 |