K946260 is an FDA 510(k) clearance for the NTBS-1417, 1436, TBS-1417. This device is classified as a Holder, Radiographic Cassette, Wall-mounted (Class I - General Controls, product code IXY).
Submitted by Scott Imaging Intl., Inc. (Mobile, US). The FDA issued a Cleared decision on March 31, 1995, 108 days after receiving the submission on December 13, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1880.
| 510(k) Number | K946260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1994 |
| Decision Date | March 31, 1995 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IXY — Holder, Radiographic Cassette, Wall-mounted |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1880 |