The following data is part of a premarket notification filed by Imaging Sciences International, Llc with the FDA for Dexis Software: Dexis Imaging Suite, Dexis Mac.
| Device ID | K140445 |
| 510k Number | K140445 |
| Device Name: | DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC |
| Classification | System, Image Processing, Radiological |
| Applicant | IMAGING SCIENCES INTERNATIONAL, LLC 1910 NORTH PENN RD. Hatfield, PA 19440 |
| Contact | Sanjay Ahuja |
| Correspondent | Sanjay Ahuja IMAGING SCIENCES INTERNATIONAL, LLC 1910 NORTH PENN RD. Hatfield, PA 19440 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-21 |
| Decision Date | 2014-04-23 |