The following data is part of a premarket notification filed by Thomson-cgr Medical Corp. with the FDA for Dg 200/300 Digital Angiographic System.
| Device ID | K852353 |
| 510k Number | K852353 |
| Device Name: | DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | THOMSON-CGR MEDICAL CORP. 10150 OLD COLUMBIA RD. Columbia, MD 21046 |
| Contact | Dennis E Upright |
| Correspondent | Dennis E Upright THOMSON-CGR MEDICAL CORP. 10150 OLD COLUMBIA RD. Columbia, MD 21046 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-03 |
| Decision Date | 1985-08-07 |