CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105
FDA 510(k) clearance K853861 · decided 1985-10-24
Clearance details
- K-number
- K853861
- Device name
- CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105
- Applicant
- Canon USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-09-17
- Decision date
- 1985-10-24
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- IJZ
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Jericho, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.