Accusketch Cardiac Quantitative System W/ Advanced Analysis Components
FDA 510(k) K023100 · General Electric Medical Systems Information Techn
510(k) numberK023100
Submission
- Device name
- Accusketch Cardiac Quantitative System W/ Advanced Analysis Components
- Applicant
- General Electric Medical Systems Information Techn
Milwaukee, WI, US - Received
- September 18, 2002
- Decision date
- October 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Accusketch Cardiac Quantitative System W/ Advanced Analysis Components cleared by the FDA?
Accusketch Cardiac Quantitative System W/ Advanced Analysis Components (K023100) received a 510(k) decision of Substantially Equivalent on October 11, 2002, 23 days after the submission was received.
What is the product code of K023100?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.