Cleared Traditional

Infinitt RT PACS

K193498 · Infinitt Healthcare Co., Ltd. · Radiology

Feb 2020

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K193498 is an FDA 510(k) clearance for the Infinitt RT PACS, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Infinitt Healthcare Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on February 13, 2020, 58 days after receiving the submission on December 17, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K193498 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 2019
Decision Date	February 13, 2020
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF