The following data is part of a premarket notification filed by Dynamic Digital Displays, Inc. with the FDA for Voxelscope(tm).
| Device ID | K884268 |
| 510k Number | K884268 |
| Device Name: | VOXELSCOPE(TM) |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | DYNAMIC DIGITAL DISPLAYS, INC. 3508 MARKET ST. SUITE 257 Philadelphia, PA 19104 |
| Contact | David A Talton |
| Correspondent | David A Talton DYNAMIC DIGITAL DISPLAYS, INC. 3508 MARKET ST. SUITE 257 Philadelphia, PA 19104 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-11 |
| Decision Date | 1988-12-20 |