Clearance Summary
LUMAGEM MOLECULAR BREAST IMAGING SYSTEM received FDA 510(k) clearance under submission number K111791, 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 2011-09-23.
- Submission: K111791
- Applicant / Sponsor: Gamma Medica-Ideas Incorporated
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 2011-09-23
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.