The following data is part of a premarket notification filed by Analogic Corp. with the FDA for An5150 And An7150 Digital Radiology Systems.
| Device ID | K033345 |
| 510k Number | K033345 |
| Device Name: | AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS |
| Classification | System, X-ray, Stationary |
| Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Contact | Marvin Rosenbaum |
| Correspondent | Marvin Rosenbaum ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-20 |
| Decision Date | 2003-11-19 |
| Summary: | summary |