Clearance Summary
VERISTA IMAGING ISOCAM II GAMMA CAMERA received FDA 510(k) clearance under submission number K081757, sponsored by Verista Imaging, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-08-15.
- Submission: K081757
- Applicant / Sponsor: Verista Imaging, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 2008-08-15
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.