The following data is part of a premarket notification filed by Neologica S.r.l. with the FDA for Remoteye Viewer.
| Device ID | K141061 |
| 510k Number | K141061 |
| Device Name: | REMOTEYE VIEWER |
| Classification | System, Image Processing, Radiological |
| Applicant | NEOLOGICA S.R.L. STRADA VILLE, 58 - 17014 Cairo Montenotte (sv), IT It |
| Contact | Marco Sambin |
| Correspondent | Marco Sambin NEOLOGICA S.R.L. STRADA VILLE, 58 - 17014 Cairo Montenotte (sv), IT It |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-24 |
| Decision Date | 2014-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B383REV090203000 | K141061 | 000 |
| B383REV090202000 | K141061 | 000 |
| B383REV090201000 | K141061 | 000 |
| B383REV090200000 | K141061 | 000 |
| B383REV090102000 | K141061 | 000 |
| B383REV100001000 | K141061 | 000 |
| B383REV100000000 | K141061 | 000 |
| B383REV090204000 | K141061 | 000 |
| B383REV100002000 | K141061 | 000 |