Clearance Summary
X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 received FDA 510(k) clearance under submission number K910308, sponsored by Inmark 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 1991-03-27.
- Submission: K910308
- Applicant / Sponsor: Inmark Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1760
- Decision date: 1991-03-27
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.