The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Retinavue Network Ref 901108 Pacs Medical Image System.
| Device ID | K181016 |
| 510k Number | K181016 |
| Device Name: | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Welch Allyn, Inc. 4341 State Street Rd. Skaneateles Falls, NY 13153 |
| Contact | Megan Pellenz |
| Correspondent | Megan Pellenz Welch Allyn, Inc. 4341 State Street Rd. Skaneateles Falls, NY 13153 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-17 |
| Decision Date | 2018-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094223910 | K181016 | 000 |