Clearance Summary
Blue Phantom PT received FDA 510(k) clearance under submission number K191821, sponsored by Iba Dosimetry GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-01-23.
- Submission: K191821
- Applicant / Sponsor: Iba Dosimetry GmbH
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2020-01-23
Classification & Regulation
This clearance is catalogued under FDA product code LHN and 21 CFR 892.5050, within the Radiology review panel as a Class II device.