The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Anatom 1000 (a Minus, A-).
| Device ID | K974455 |
| 510k Number | K974455 |
| Device Name: | ANATOM 1000 (A MINUS, A-) |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-25 |
| Decision Date | 1998-02-20 |
| Summary: | summary |