The following data is part of a premarket notification filed by Sectra Ab with the FDA for Ids5 Image Display System.
| Device ID | K001140 |
| 510k Number | K001140 |
| Device Name: | IDS5 IMAGE DISPLAY SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | SECTRA AB 2001 EAST OAKSHORES DR. Crossroads, TX 76227 |
| Contact | Herman Oosterwijk |
| Correspondent | Herman Oosterwijk SECTRA AB 2001 EAST OAKSHORES DR. Crossroads, TX 76227 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-05-03 |