K894142 is an FDA 510(k) clearance for the ULTRANET-S COLLIMATOR. This device is classified as a Collimator, Automatic, Radiographic (Class II - Special Controls, product code IZW).
Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on November 6, 1989, 146 days after receiving the submission on June 13, 1989.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1610.
| 510(k) Number | K894142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 1989 |
| Decision Date | November 06, 1989 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | IZW - Collimator, Automatic, Radiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1610 |