The following data is part of a premarket notification filed by Sectra-imtec Ab with the FDA for Sectra Ids5 Radiology Workstation; Sectra Mpr Package; Sectra 3d Package.
| Device ID | K040376 |
| 510k Number | K040376 |
| Device Name: | SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE |
| Classification | System, Image Processing, Radiological |
| Applicant | SECTRA-IMTEC AB 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto SECTRA-IMTEC AB 1600 MANCHESTER WAY Corinth, TX 76210 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-05-04 |
| Summary: | summary |