The following data is part of a premarket notification filed by Canon, Inc.-medical Equipment Group with the FDA for Digital Radiography.
| Device ID | K102012 |
| 510k Number | K102012 |
| Device Name: | DIGITAL RADIOGRAPHY |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CANON, INC.-MEDICAL EQUIPMENT GROUP 3F 2-17-6 AKEBONO-CHO Tachikawa-shi, Tokyo, JP 190-0012 |
| Contact | Koji Kubo |
| Correspondent | Koji Kubo CANON, INC.-MEDICAL EQUIPMENT GROUP 3F 2-17-6 AKEBONO-CHO Tachikawa-shi, Tokyo, JP 190-0012 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-16 |
| Decision Date | 2010-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04960999974965 | K102012 | 000 |