Q Lab Software
FDA 510(k) K021966 · Advanced Technology Laboratories, Inc.
510(k) numberK021966
Submission
- Device name
- Q Lab Software
- Applicant
- Advanced Technology Laboratories, Inc.
Bothell, WA, US - Received
- June 17, 2002
- Decision date
- July 2, 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 Q Lab Software cleared by the FDA?
Q Lab Software (K021966) received a 510(k) decision of Substantially Equivalent on July 2, 2002, 15 days after the submission was received.
What is the product code of K021966?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.