Clearance Summary
DELTA 32; DELTA 32 TACT received FDA 510(k) clearance under submission number K022275, sponsored by Instrumentarium Corp. Imaging Division. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2002-09-12.
- Submission: K022275
- Applicant / Sponsor: Instrumentarium Corp. Imaging Division
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1710
- Decision date: 2002-09-12
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.