Clearance Summary
CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105 received FDA 510(k) clearance under submission number K853861, sponsored by Canon USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1985-10-24.
- Submission: K853861
- Applicant / Sponsor: Canon USA, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1985-10-24
Classification & Regulation
This clearance is catalogued under FDA product code IJZ and 21 CFR 864.4010, within the Pathology review panel as a Class I device.