K781675 is an FDA 510(k) clearance for the X-RAY COLLIMATOR. This device is classified as a Collimator, X-ray (Class I - General Controls, product code EHB).
Submitted by General X-Ray, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978, 66 days after receiving the submission on September 29, 1978.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1840.
| 510(k) Number | K781675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 1978 |
| Decision Date | December 04, 1978 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | EHB — Collimator, X-ray |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.1840 |