Clearance Summary
NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS received FDA 510(k) clearance under submission number K860472, sponsored by Nuclear Diagnostics, 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 1986-07-03.
- Submission: K860472
- Applicant / Sponsor: Nuclear Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.5780
- Decision date: 1986-07-03
Classification & Regulation
This clearance is catalogued under FDA product code IWE and 21 CFR 892.5780, within the Radiology review panel as a Class I device.