Cleared Traditional

K180916 - iNtuition-T1 Mapping and T2/T2* Mapping (FDA 510(k) Clearance)

K180916 · Terarecon,Inc. · Radiology device

Sep 2018

Decision

168d

Days

Class 2

Risk

K180916 is an FDA 510(k) clearance for the iNtuition-T1 Mapping and T2/T2* Mapping. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Terarecon,Inc. (Foster City, US). The FDA issued a Cleared decision on September 24, 2018, 168 days after receiving the submission on April 9, 2018.

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

Submission Details

510(k) Number	K180916 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 09, 2018
Decision Date	September 24, 2018
Days to Decision	168 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF