Clearance Summary
ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 received FDA 510(k) clearance under submission number K090296, sponsored by Biodex Medical Systems, 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 2009-02-19.
- Submission: K090296
- Applicant / Sponsor: Biodex Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1360
- Decision date: 2009-02-19
Classification & Regulation
This clearance is catalogued under FDA product code KPT and 21 CFR 892.1360, within the Radiology review panel as a Class II device.