The following data is part of a premarket notification filed by Imaging Sciences International /gendex/dexis with the FDA for Dexis Webview.
| Device ID | K151941 |
| 510k Number | K151941 |
| Device Name: | DEXIS Webview |
| Classification | System, Image Processing, Radiological |
| Applicant | Imaging Sciences International /Gendex/Dexis 1910 North Penn Road Hatfield, PA 19440 |
| Contact | Sanjay Ahuja |
| Correspondent | Sanjay Ahuja Imaging Sciences International /Gendex/Dexis 1910 North Penn Road Hatfield, PA 19440 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-14 |
| Decision Date | 2015-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV101135330 | K151941 | 000 |
| EKAV101244750 | K151941 | 000 |