Clearance Summary
OPTI 110/12/50 HSG received FDA 510(k) clearance under submission number K781540, sponsored by Siemens 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 1978-09-14.
- Submission: K781540
- Applicant / Sponsor: Siemens Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1760
- Decision date: 1978-09-14
Classification & Regulation
This clearance is catalogued under FDA product code ITY and 21 CFR 892.1760, within the Radiology review panel as a Class I device.