Clearance Summary
POWER-AID INDEPENDENT X-RAY POWER SOURCE received FDA 510(k) clearance under submission number K872445, sponsored by Advanced Instrument Development, 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 1987-08-12.
- Submission: K872445
- Applicant / Sponsor: Advanced Instrument Development, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1700
- Decision date: 1987-08-12
Classification & Regulation
This clearance is catalogued under FDA product code IZO and 21 CFR 892.1700, within the Radiology review panel as a Class I device.