NemoScan

FDA 510(k) K192571 · Software Nemotec S.L.

Substantially Equivalent

510(k) numberK192571

Submission

Device name
NemoScan
Applicant
Software Nemotec S.L.
Arroyomolinos, Madrid, ES
Received
September 18, 2019
Decision date
December 11, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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More from Avara Software

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K232698NemoScanQIH · Traditional 01/18/2024SE
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Questions and answers

When was NemoScan cleared by the FDA?

NemoScan (K192571) received a 510(k) decision of Substantially Equivalent on December 11, 2019, 84 days after the submission was received.

What is the product code of K192571?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.