Sectra IDS5 Workstation
FDA 510(k) K050196 · Sectra Imtec AB
510(k) numberK050196
Submission
- Device name
- Sectra IDS5 Workstation
- Applicant
- Sectra Imtec AB
Denton, TX, US - Received
- January 27, 2005
- Decision date
- February 24, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from Avara Software
| 510(k) | Device | Decision |
|---|---|---|
| K110025 | Sectra Microdose MammographyMUE · Traditional | 04/28/2011SE |
| K081469 | Sectra Workstation, IDS7 Version 11.3, IDS5 Version 11.1 P2LLZ · Special | 06/12/2008SE |
| K063093 | Sectra Workstation, Version 11.1LLZ · Special | 11/07/2006SE |
| K051315 | Modification to: Sectra IDS5 WorkstationLLZ · Special | 06/15/2005SE |
| K040376 | Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D PackageLLZ · Special | 05/04/2004SE |
| K033712 | Modification to Sectra IDS5 Radiology Workstation - Version 10.1LLZ · Special | 12/23/2003SE |
| K031590 | Sectra Orthopedic PackageLLZ · Traditional | 10/02/2003SE |
| K021527 | Sectra Osteoporosis PackageKGI · Special | 06/07/2002SE |
| K002936 | Modification to IDS5 Image Display SystemLLZ · Special | 10/17/2000SE |
| K983447 | Wise (II) Image Management SystemLMB · Special | 10/29/1998SE |
Questions and answers
When was Sectra IDS5 Workstation cleared by the FDA?
Sectra IDS5 Workstation (K050196) received a 510(k) decision of Substantially Equivalent on February 24, 2005, 28 days after the submission was received.
What is the product code of K050196?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.