The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Registrex 1000 Digital Radiography Sys.
| Device ID | K833230 |
| 510k Number | K833230 |
| Device Name: | REGISTREX 1000 DIGITAL RADIOGRAPHY SYS |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-24 |
| Decision Date | 1983-11-21 |