Clearance Summary
X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS received FDA 510(k) clearance under submission number K901997, sponsored by Comet Ltd. C/O Radiology Resources, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-06-06.
- Submission: K901997
- Applicant / Sponsor: Comet Ltd. C/O Radiology Resources, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1710
- Decision date: 1990-06-06
Classification & Regulation
This clearance is catalogued under FDA product code IZH and 21 CFR 892.1710, within the Radiology review panel as a Class II device.