The following data is part of a premarket notification filed by Climb Medical Systems, Inc. with the FDA for Climb Mammography Viewer Software.
| Device ID | K141364 |
| 510k Number | K141364 |
| Device Name: | CLIMB MAMMOGRAPHY VIEWER SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | CLIMB MEDICAL SYSTEMS, INC. SENRI LIFE SCIENCE CENTER BLDG 10F 1-4-2 SHINSENRI HIGASHIMACHI Toyonaka-shi, Osaka, JP 560-0082 |
| Contact | Kenneth Wade |
| Correspondent | Kenneth Wade CLIMB MEDICAL SYSTEMS, INC. SENRI LIFE SCIENCE CENTER BLDG 10F 1-4-2 SHINSENRI HIGASHIMACHI Toyonaka-shi, Osaka, JP 560-0082 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-23 |
| Decision Date | 2014-08-29 |
| Summary: | summary |