The following data is part of a premarket notification filed by Sectra Imtec Ab with the FDA for Sectra Workstation, Ids7 Version 11.3, Ids5 Version 11.1 P2.
| Device ID | K081469 |
| 510k Number | K081469 |
| Device Name: | SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 |
| Classification | System, Image Processing, Radiological |
| Applicant | SECTRA IMTEC AB 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alleto |
| Correspondent | Carl Alleto 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 | 2008-05-27 |
| Decision Date | 2008-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350092810159 | K081469 | 000 |
| 07350092810470 | K081469 | 000 |
| 07350092810449 | K081469 | 000 |
| 07350092810418 | K081469 | 000 |
| 07350092810371 | K081469 | 000 |
| 07350092810357 | K081469 | 000 |
| 07350092810326 | K081469 | 000 |
| 07350092810265 | K081469 | 000 |
| 07350092810210 | K081469 | 000 |
| 07350092810234 | K081469 | 000 |
| 07350092810012 | K081469 | 000 |
| 07350092810036 | K081469 | 000 |
| 07350092810050 | K081469 | 000 |
| 07350092810067 | K081469 | 000 |
| 07350092810074 | K081469 | 000 |
| 07350092810098 | K081469 | 000 |
| 07350092810517 | K081469 | 000 |