Clearance Summary
MOLECULAR BREAST IMAGING SOFTWARE received FDA 510(k) clearance under submission number K111731, sponsored by Gamma Medica-Ideas Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-09-15.
- Submission: K111731
- Applicant / Sponsor: Gamma Medica-Ideas Incorporated
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2011-09-15
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.