Cerner Provision Workstation (Version 2.5)
FDA 510(k) K091032 · Cerner Corp.
510(k) numberK091032
Submission
- Device name
- Cerner Provision Workstation (Version 2.5)
- Applicant
- Cerner Corp.
Kansas City, MO, US - Received
- April 10, 2009
- Decision date
- June 22, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K070394 | Cerner Provision WorkstationLLZ · Traditional | 03/27/2007SE |
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Questions and answers
When was Cerner Provision Workstation (Version 2.5) cleared by the FDA?
Cerner Provision Workstation (Version 2.5) (K091032) received a 510(k) decision of Substantially Equivalent on June 22, 2009, 73 days after the submission was received.
What is the product code of K091032?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.