The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon X-ray I.i. Rapid Sequence Camera Crs-105.
| Device ID | K853861 |
| 510k Number | K853861 |
| Device Name: | CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105 |
| Classification | Oil, Clearing |
| Applicant | CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
| Contact | Tamada |
| Correspondent | Tamada CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
| Product Code | IJZ |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-17 |
| Decision Date | 1985-10-24 |