K780319 is an FDA 510(k) clearance for the ORBITOME-UG. This device is classified as a System, X-ray, Tomographic (Class II - Special Controls, product code IZF).
Submitted by Philips Medical Systems (Cleveland), Inc. (Walker, US). The FDA issued a Cleared decision on March 14, 1978, 18 days after receiving the submission on February 24, 1978.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1740.
| 510(k) Number | K780319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 1978 |
| Decision Date | March 14, 1978 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IZF — System, X-ray, Tomographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1740 |