Submission Details
| 510(k) Number | K023750 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 08, 2002 |
| Decision Date | November 22, 2002 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
K023750 is an FDA 510(k) clearance for the CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on November 22, 2002, 14 days after receiving the submission on November 8, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K023750 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 08, 2002 |
| Decision Date | November 22, 2002 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MQB — Solid State X-ray Imager (flat Panel/digital Imager) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1680 |