GMR40— 510(k) K171085

Substantially Equivalent

Neurologica Corporation, A Subsidiary OF

FDA 510(k) clearance K171085 for GMR40, Substantially Equivalent on 2017-05-11. Applicant: Neurologica Corporation, A Subsidiary OF. Device class: 2.

Clearance details

Applicant: Neurologica Corporation, A Subsidiary OF
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2017-04-12
Decision date: 2017-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K171085

K-number listed on FDA's recall record

Z-1391-2018 — Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) MedicalClass II·Terminated·NeuroLogica Corporation·20180112

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171085.

Data sourced from openFDA. This site is unofficial and independent of the FDA.