K810194 is an FDA 510(k) clearance for the WALL CASSETTE HOLDER - TRAC44. This device is classified as a Holder, Radiographic Cassette, Wall-mounted (Class I - General Controls, product code IXY).
Submitted by Philips Medical Systems (Cleveland), Inc. (Mchenry, US). The FDA issued a Cleared decision on February 25, 1981, 33 days after receiving the submission on January 23, 1981.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1880.
| 510(k) Number | K810194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1981 |
| Decision Date | February 25, 1981 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IXY — Holder, Radiographic Cassette, Wall-mounted |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1880 |