K970240 is an FDA 510(k) clearance for the DIFFUSER PANEL. This device is classified as a Illuminator, Radiographic-film (Class I - General Controls, product code IXC).
Submitted by Focused Viewer, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on March 11, 1997, 48 days after receiving the submission on January 22, 1997.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1890.
| 510(k) Number | K970240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1997 |
| Decision Date | March 11, 1997 |
| Days to Decision | 48 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 |