The following data is part of a premarket notification filed by Analogic Corporation with the FDA for Synepix 4600 Detector.
| Device ID | K070829 |
| 510k Number | K070829 |
| Device Name: | SYNEPIX 4600 DETECTOR |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | ANALOGIC CORPORATION 8 CENTENNIAL DR. Peabody, MA 01960 |
| Contact | Donald J Sherratt |
| Correspondent | Donald J Sherratt ANALOGIC CORPORATION 8 CENTENNIAL DR. Peabody, MA 01960 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-05-09 |
| Summary: | summary |