The following data is part of a premarket notification filed by Sectra-imtec Ab with the FDA for Smiic (sectra Medical Image Input Controller).
| Device ID | K965161 |
| 510k Number | K965161 |
| Device Name: | SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) |
| Classification | System, Digital Image Communications, 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 | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-03-12 |