Clearance Summary
PORTA. X-RAY UNIT FP220 SCM-1-ETC, received FDA 510(k) clearance under submission number K833239, sponsored by Showa X-Ray Co., 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 1983-11-21.
- Submission: K833239
- Applicant / Sponsor: Showa X-Ray Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 1983-11-21
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.