The following data is part of a premarket notification filed by Imasight Inc with the FDA for Imasight 4600 Digital Radiography Sensor.
| Device ID | K092307 |
| 510k Number | K092307 |
| Device Name: | IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR |
| Classification | System, X-ray, Stationary |
| Applicant | IMASIGHT INC 10-925 DE LA CARRIERE BLVD Gatineau, Quebec, CA J8y 6w5 |
| Contact | Jean Casault |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-07-30 |
| Decision Date | 2009-08-25 |
| Summary: | summary |