The following data is part of a premarket notification filed by Ebm Technologies Incorporated with the FDA for Ebm Ido Viewer 1.2.1.
| Device ID | K162285 |
| 510k Number | K162285 |
| Device Name: | EBM IDO Viewer 1.2.1 |
| Classification | System, Image Processing, Radiological |
| Applicant | EBM Technologies Incorporated 5F., No. 516, Sec. 1, Neihu Rd Taipei, TW 114 |
| Contact | John Su |
| Correspondent | John Su EBM Technologies Incorporated 5F., No. 516, Sec. 1, Neihu Rd Taipei, TW 114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-15 |
| Decision Date | 2017-01-27 |
| Summary: | summary |