Clearance Summary
DI2000/HS-45-150 X-RAY TUBE INSERT received FDA 510(k) clearance under submission number K910842, 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 1991-03-06.
- Submission: K910842
- Applicant / Sponsor: Comet Ltd. C/O Radiology Resources, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1760
- Decision date: 1991-03-06
Classification & Regulation
This clearance is catalogued under FDA product code ITY and 21 CFR 892.1760, within the Radiology review panel as a Class I device.