The following data is part of a premarket notification filed by Sectra Ab with the FDA for Sectra Ids5 Radiology Workstation Version 10.1.
| Device ID | K033088 |
| 510k Number | K033088 |
| Device Name: | SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 |
| Classification | System, Image Processing, Radiological |
| Applicant | SECTRA AB 1100 LAKEVIEW BLVD. Denton, TX 76208 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto SECTRA AB 1100 LAKEVIEW BLVD. Denton, TX 76208 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2003-10-29 |
| Summary: | summary |