Clearance Summary
HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE received FDA 510(k) clearance under submission number K913264, sponsored by Mallinckrodt Group, 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 1991-11-01.
- Submission: K913264
- Applicant / Sponsor: Mallinckrodt Group, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1991-11-01
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.