ACIES

System, Image Processing, Radiological

KONICA MINOLTA MEDICAL & GRAPHIC, INC.

The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Acies.

Pre-market Notification Details

• Device ID: K101842
• 510k Number: K101842
• Device Name: ACIES
• Classification: System, Image Processing, Radiological
• Applicant: KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER New York, NY 10017
• Contact: Russell Munves
• Correspondent: Russell Munves; KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER New York, NY 10017
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-07-01
• Decision Date: 2011-02-04
• Summary: summary