Cleared Traditional

Voxel Dosimetry? v1.0

K191216 · Hermes Medical Solutions AB · Radiology
Oct 2019
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K191216 is an FDA 510(k) clearance for the Voxel Dosimetry? v1.0, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Hermes Medical Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on October 17, 2019, 164 days after receiving the submission on May 6, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K191216 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2019
Decision Date October 17, 2019
Days to Decision 164 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050