Clearance Summary
X-RAY UNIT, PORTABLE GX-101 AEC received FDA 510(k) clearance under submission number K781030, sponsored by General X-Ray, 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 1978-07-17.
- Submission: K781030
- Applicant / Sponsor: General X-Ray, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 1978-07-17
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.