The following data is part of a premarket notification filed by Electronic Business Machine Co., Ltd. (ebm) with the FDA for Unisight Mammography Viewer, Model 4.0.
| Device ID | K062743 |
| 510k Number | K062743 |
| Device Name: | UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) 1600 KAPIOLANI BLVD. SUITE 1300 Honolulu, HI 96814 |
| Contact | Jeffrey Chern |
| Correspondent | Jeffrey Chern ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) 1600 KAPIOLANI BLVD. SUITE 1300 Honolulu, HI 96814 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-14 |
| Decision Date | 2006-10-31 |