Clearance Summary
HDR 1000 PLUS WELL CHAMBER, MODEL 90008 received FDA 510(k) clearance under submission number K060532, sponsored by Standard Imaging, 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 2006-04-11.
- Submission: K060532
- Applicant / Sponsor: Standard Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 2006-04-11
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.