The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Dr9000 Digital Radiography X-ray System.
| Device ID | K001336 |
| 510k Number | K001336 |
| Device Name: | DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Contact | Robert H French |
| Correspondent | Robert H French ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-27 |
| Decision Date | 2000-06-02 |