The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon X-ray Digital Camera, Model Cxdi-22.
Device ID | K992547 |
510k Number | K992547 |
Device Name: | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
Contact | Ken Shadoff |
Correspondent | Ken Shadoff CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-30 |
Decision Date | 1999-10-13 |
Summary: | summary |