X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R
FDA 510(k) clearance K871116 · decided 1987-05-14
Clearance details
- K-number
- K871116
- Device name
- X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R
- Applicant
- X-Cel X-Ray Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-19
- Decision date
- 1987-05-14
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- IYH
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Crystal Lake, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.