The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Synerad Omni, Digital X-ray System, Model An6250.
| Device ID | K043025 |
| 510k Number | K043025 |
| Device Name: | SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 |
| Classification | System, X-ray, Stationary |
| Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. CENTENNIAL INDUSTRIAL PARK Peabody, MA 01960 |
| Contact | Donald J Sherratt |
| Correspondent | Donald J Sherratt ANALOGIC CORP. 8 CENTENNIAL DR. CENTENNIAL INDUSTRIAL PARK Peabody, MA 01960 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-03 |
| Decision Date | 2004-11-19 |
| Summary: | summary |