Cleared Traditional

K102849 - ACCULMAING (FDA 510(k) Clearance)

K102849 · Radiology Information Systems, Inc. · Radiology device
Nov 2010
Decision
55d
Days
Class 2
Risk

K102849 is an FDA 510(k) clearance for the ACCULMAING. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Radiology Information Systems, Inc. (Crofton, US). The FDA issued a Cleared decision on November 23, 2010, 55 days after receiving the submission on September 29, 2010.

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

Submission Details

510(k) Number K102849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date November 23, 2010
Days to Decision 55 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