The following data is part of a premarket notification filed by Technicare Corp. with the FDA for Digital Subtraction Radiography System.
| Device ID | K801948 |
| 510k Number | K801948 |
| Device Name: | DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | TECHNICARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-15 |
| Decision Date | 1980-09-26 |