| Primary Device ID | 07350092810012 |
| NIH Device Record Key | c8c7190a-91bc-4e22-9756-04bbcfcdf33d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sectra Workstation IDS7 |
| Version Model Number | 18.2 |
| Company DUNS | 354117848 |
| Company Name | Sectra AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +4613235200 |
| regulatoryaffairs@sectra.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350092810012 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-21 |
| 07350092810500 - Sectra Digital Pathology Module | 2024-05-15 For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital |
| 07350092810494 - Sectra Orthopedic Package | 2024-01-10 Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measure |
| 07350092810487 - Sectra Digital Pathology Module | 2023-11-21 For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital |
| 07350092810470 - Sectra Workstation | 2023-11-20 Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) an |
| 07350092810449 - Sectra Workstation | 2023-06-29 Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) an |
| 07350092810456 - Sectra Digital Pathology Module | 2023-06-29 For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital |
| 07350092810463 - Sectra Orthopedic Package | 2023-06-29 Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measure |
| 07350092810395 - Sectra Calibration Unit | 2022-11-15 The Sectra Calibration Unit consists of calibration holders and markers. The calibration holders are intended to correctly place |