The following data is part of a premarket notification filed by Gamma Medica-ideas Incorporated with the FDA for Molecular Breast Imaging Software.
| Device ID | K111731 |
| 510k Number | K111731 |
| Device Name: | MOLECULAR BREAST IMAGING SOFTWARE |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-20 |
| Decision Date | 2011-09-15 |
| Summary: | summary |