The following data is part of a premarket notification filed by Dr Systems, Inc with the FDA for Dr Systems Zero Download 3d Viewer (z3d).
| Device ID | K143318 |
| 510k Number | K143318 |
| Device Name: | DR Systems Zero Download 3D Viewer (Z3D) |
| Classification | System, Image Processing, Radiological |
| Applicant | DR Systems, Inc 10140 Mesa Rim Road San Diego, CA 92121 |
| Contact | Kimberly J Meade |
| Correspondent | Kimberly J Meade DR Systems, Inc 10140 Mesa Rim Road San Diego, CA 92121 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-19 |
| Decision Date | 2015-03-10 |
| Summary: | summary |