Modification to Sectra IDS5 Radiology Workstation - Version 10.1
FDA 510(k) K033712 · Sectra-Imtec AB
510(k) numberK033712
Submission
- Device name
- Modification to Sectra IDS5 Radiology Workstation - Version 10.1
- Applicant
- Sectra-Imtec AB
Denton, TX, US - Received
- November 26, 2003
- Decision date
- December 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K110025 | Sectra Microdose MammographyMUE · Traditional | 04/28/2011SE |
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| K051315 | Modification to: Sectra IDS5 WorkstationLLZ · Special | 06/15/2005SE |
| K050196 | Sectra IDS5 WorkstationLLZ · Special | 02/24/2005SE |
| K040376 | Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D PackageLLZ · Special | 05/04/2004SE |
| K031590 | Sectra Orthopedic PackageLLZ · Traditional | 10/02/2003SE |
| K021527 | Sectra Osteoporosis PackageKGI · Special | 06/07/2002SE |
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Questions and answers
When was Modification to Sectra IDS5 Radiology Workstation - Version 10.1 cleared by the FDA?
Modification to Sectra IDS5 Radiology Workstation - Version 10.1 (K033712) received a 510(k) decision of Substantially Equivalent on December 23, 2003, 27 days after the submission was received.
What is the product code of K033712?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.