The following data is part of a premarket notification filed by Kub Technologies, Inc with the FDA for Kubtec Digiview 395.
| Device ID | K151221 |
| 510k Number | K151221 |
| Device Name: | Kubtec DIGIVIEW 395 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | KUB TECHNOLOGIES, INC 270 ROWE AVENUE, UNIT E Milford, CT 06461 |
| Contact | Vikram Butani |
| Correspondent | Vikram Butani KUB TECHNOLOGIES, INC 270 ROWE AVENUE, UNIT E Milford, CT 06461 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-07 |
| Decision Date | 2015-06-23 |
| Summary: | summary |