Clearance Summary
ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 received FDA 510(k) clearance under submission number K023373, sponsored by Gvi Technology Partners. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-01-03.
- Submission: K023373
- Applicant / Sponsor: Gvi Technology Partners
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 2003-01-03
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.