Clearance Summary
ARRIPRO 35 ST/TV received FDA 510(k) clearance under submission number K973115, sponsored by Arnold & Richter Cine Technik. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-09-02.
- Submission: K973115
- Applicant / Sponsor: Arnold & Richter Cine Technik
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1890
- Decision date: 1997-09-02
Classification & Regulation
This clearance is catalogued under FDA product code IXC and 21 CFR 892.1890, within the Radiology review panel as a Class I device.