Clearance Summary
CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS received FDA 510(k) clearance under submission number K932701, sponsored by Nuccardiac Software, 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 1994-03-29.
- Submission: K932701
- Applicant / Sponsor: Nuccardiac Software, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 1994-03-29
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.