Clearance Summary
CAMERA, GAMMA received FDA 510(k) clearance under submission number K780060, sponsored by Ackerman-Schmehl Industries, 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 1978-01-26.
- Submission: K780060
- Applicant / Sponsor: Ackerman-Schmehl Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 1978-01-26
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.