The following data is part of a premarket notification filed by Sectra-imtec Ab with the FDA for Trs 2000 Teleradiology System.
| Device ID | K961983 |
| 510k Number | K961983 |
| Device Name: | TRS 2000 TELERADIOLOGY SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | SECTRA-IMTEC AB 6741 GRANT LN. Plano, TX 75024 |
| Contact | Herman Oosterwijk |
| Correspondent | Herman Oosterwijk SECTRA-IMTEC AB 6741 GRANT LN. Plano, TX 75024 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-20 |
| Decision Date | 1996-08-13 |
| Summary: | summary |