Cleared Traditional

K202718 - Qmenta Care Platform Family (FDA 510(k) Clearance)

K202718 · Mint Labs, Inc., D/B/A. Qmenta · Radiology device

Jun 2021

Decision

272d

Days

Class 2

Risk

K202718 is an FDA 510(k) clearance for the Qmenta Care Platform Family. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Mint Labs, Inc., D/B/A. Qmenta (Boston, US). The FDA issued a Cleared decision on June 16, 2021, 272 days after receiving the submission on September 17, 2020.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K202718 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 17, 2020
Decision Date	June 16, 2021
Days to Decision	272 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF