The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Anatom 2000.
| Device ID | K964890 |
| 510k Number | K964890 |
| Device Name: | ANATOM 2000 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Contact | James R Levani |
| Correspondent | James R Levani 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 | 1996-12-06 |
| Decision Date | 1997-03-06 |
| Summary: | summary |