Kinetdx Picture Archiving and Communications System
FDA 510(k) K023772 · Acuson Corp.
510(k) numberK023772
Submission
- Device name
- Kinetdx Picture Archiving and Communications System
- Applicant
- Acuson Corp.
Mountainview, CA, US - Received
- November 12, 2002
- Decision date
- November 22, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Kinetdx Picture Archiving and Communications System cleared by the FDA?
Kinetdx Picture Archiving and Communications System (K023772) received a 510(k) decision of Substantially Equivalent on November 22, 2002, 10 days after the submission was received.
What is the product code of K023772?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.