The following data is part of a premarket notification filed by American Science And Engineering, Inc. with the FDA for X-ray Scanner, Computerized Tomographic.
| Device ID | K760201 |
| 510k Number | K760201 |
| Device Name: | X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | AMERICAN SCIENCE AND ENGINEERING, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-07-08 |
| Decision Date | 1976-10-05 |