QLAB Advanced Quantification Software 13
FDA 510(k) K190913 · Philips Health Care
510(k) numberK190913
Submission
- Device name
- QLAB Advanced Quantification Software 13
- Applicant
- Philips Health Care
Bothell, WA, US - Received
- April 8, 2019
- Decision date
- June 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K171314 | QLAB Advanced Quantification SoftwareLLZ · Traditional | 05/30/2017SE |
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Questions and answers
When was QLAB Advanced Quantification Software 13 cleared by the FDA?
QLAB Advanced Quantification Software 13 (K190913) received a 510(k) decision of Substantially Equivalent on June 18, 2019, 71 days after the submission was received.
What is the product code of K190913?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.