K991302 is an FDA 510(k) clearance for the SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS. This device is classified as a Illuminator, Radiographic-film (Class I - General Controls, product code IXC).
Submitted by Smartlight, Inc. (Hackensack, US). The FDA issued a Cleared decision on June 1, 1999, 46 days after receiving the submission on April 16, 1999.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1890.
| 510(k) Number | K991302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 1999 |
| Decision Date | June 01, 1999 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXC — Illuminator, Radiographic-film |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1890 |