Cleared Traditional

K231351 - Chondral Quant (FDA 510(k) Clearance)

K231351 · Siemens Medical Soultions USA, Inc. · Radiology device

Jul 2023

Decision

65d

Days

Class 2

Risk

K231351 is an FDA 510(k) clearance for the Chondral Quant. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Siemens Medical Soultions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on July 13, 2023, 65 days after receiving the submission on May 9, 2023.

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

Submission Details

510(k) Number	K231351 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 09, 2023
Decision Date	July 13, 2023
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF