Clearance Summary
AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ received FDA 510(k) clearance under submission number K924458, sponsored by Acoustic Imaging Technologies Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1993-01-21.
- Submission: K924458
- Applicant / Sponsor: Acoustic Imaging Technologies Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1993-01-21
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.