The following data is part of a premarket notification filed by Gamma Medica-ideas Incorporated with the FDA for Lumagem Molecular Breast Imaging System.
| Device ID | K111791 |
| 510k Number | K111791 |
| Device Name: | LUMAGEM MOLECULAR BREAST IMAGING SYSTEM |
| Classification | Camera, Scintillation (gamma) |
| Applicant | GAMMA MEDICA-IDEAS INCORPORATED 755 N. MATHILDA AVENUE SUITE 100 Sunnyvale, CA 94085 |
| Contact | Albert Boniske |
| Correspondent | Albert Boniske GAMMA MEDICA-IDEAS INCORPORATED 755 N. MATHILDA AVENUE SUITE 100 Sunnyvale, CA 94085 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-27 |
| Decision Date | 2011-09-23 |
| Summary: | summary |