Clearance Summary
SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 received FDA 510(k) clearance under submission number K043379, sponsored by Shimadzu Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-02-17.
- Submission: K043379
- Applicant / Sponsor: Shimadzu Corp.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2005-02-17
Classification & Regulation
This clearance is catalogued under FDA product code OXO and 21 CFR 892.1650, within the Radiology review panel as a Class II device.