The following data is part of a premarket notification filed by Sectra Imtec Ab with the FDA for Modification To: Sectra Ids5 Workstation.
| Device ID | K051315 |
| 510k Number | K051315 |
| Device Name: | MODIFICATION TO: SECTRA IDS5 WORKSTATION |
| 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 | 2005-05-20 |
| Decision Date | 2005-06-15 |
| Summary: | summary |