Cleared Traditional

K222781 - Augmento (FDA 510(k) Clearance)

K222781 · Deeptek Medical Imaging Private Limited · Radiology device

Apr 2023

Decision

208d

Days

Class 2

Risk

K222781 is an FDA 510(k) clearance for the Augmento. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Deeptek Medical Imaging Private Limited (Pune, IN). The FDA issued a Cleared decision on April 11, 2023, 208 days after receiving the submission on September 15, 2022.

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

Submission Details

510(k) Number	K222781 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 15, 2022
Decision Date	April 11, 2023
Days to Decision	208 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF