Clearance Summary
X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R received FDA 510(k) clearance under submission number K871116, sponsored by X-Cel X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1987-05-14.
- Submission: K871116
- Applicant / Sponsor: X-Cel X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5900
- Decision date: 1987-05-14
Classification & Regulation
This clearance is catalogued under FDA product code IYH and 21 CFR 892.5900, within the Radiology review panel as a Class II device.