The following data is part of a premarket notification filed by Change Healthcare Canada Company with the FDA for Change Healthcare Enterprise Viewer.
| Device ID | K181185 |
| 510k Number | K181185 |
| Device Name: | Change Healthcare Enterprise Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | Change Healthcare Canada Company 10711 Cambie Road Richmond, CA V6x3g5 |
| Contact | Nadia Marchant |
| Correspondent | Nadia Marchant Change Healthcare Technologies LLC. 10711 Cambie Road Richmond, CA V6x3g5 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-03 |
| Decision Date | 2018-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17540262010022 | K181185 | 000 |
| 17540262010046 | K181185 | 000 |
| 17540262130126 | K181185 | 000 |
| 17540262130133 | K181185 | 000 |
| 17540262130140 | K181185 | 000 |
| 17540262130157 | K181185 | 000 |
| 17540262130164 | K181185 | 000 |
| 17540262010053 | K181185 | 000 |
| 17540262130171 | K181185 | 000 |
| 17540262130188 | K181185 | 000 |
| 17540262130119 | K181185 | 000 |
| 17540262130102 | K181185 | 000 |
| 17540262130096 | K181185 | 000 |
| 17540262010039 | K181185 | 000 |
| 17540262130010 | K181185 | 000 |
| 17540262130027 | K181185 | 000 |
| 17540262130034 | K181185 | 000 |
| 17540262130041 | K181185 | 000 |
| 17540262130058 | K181185 | 000 |
| 17540262130065 | K181185 | 000 |
| 17540262130072 | K181185 | 000 |
| 17540262130089 | K181185 | 000 |
| 17540262130195 | K181185 | 000 |