The following data is part of a premarket notification filed by Electron Jsco. with the FDA for Digital X-ray Detectors Family Krc And Dira.
| Device ID | K093640 |
| 510k Number | K093640 |
| Device Name: | DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA |
| Classification | System, Imaging, X-ray, Electrostatic |
| Applicant | ELECTRON JSCO. 55 NORTHERN BLV SUITE 200 Great Neck, NY 11021 |
| Contact | Tanmay Shukla |
| Correspondent | Tanmay Shukla ELECTRON JSCO. 55 NORTHERN BLV SUITE 200 Great Neck, NY 11021 |
| Product Code | IXK |
| CFR Regulation Number | 892.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-24 |
| Decision Date | 2011-04-29 |