Acies

FDA 510(k) K101842 · Konica Minolta Medical & Graphic, Inc.

Substantially Equivalent

510(k) numberK101842

Submission

Device name
Acies
Applicant
Konica Minolta Medical & Graphic, Inc.
New York, NY, US
Received
July 1, 2010
Decision date
February 4, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Acies cleared by the FDA?

Acies (K101842) received a 510(k) decision of Substantially Equivalent on February 4, 2011, 218 days after the submission was received.

What is the product code of K101842?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.