Clearance Summary
MISTAR, MODEL V3.2 received FDA 510(k) clearance under submission number K043350, sponsored by Apollo Medical Imaging Technology Pty. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2004-12-15.
- Submission: K043350
- Applicant / Sponsor: Apollo Medical Imaging Technology Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2004-12-15
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.