Clearance Summary
Constellation (CON-001) received FDA 510(k) clearance under submission number K241280, sponsored by Q Bio, 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 2024-09-12.
- Submission: K241280
- Applicant / Sponsor: Q Bio, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2024-09-12
Classification & Regulation
This clearance is catalogued under FDA product code QIH and 21 CFR 892.2050, within the Radiology review panel as a Class II device.