# K101842: ACIES

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta Medical & Graphic, Inc.
- Decided: Feb 4, 2011 after 218 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913770 (1991). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062107: Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003, Hologic, Inc. (2006) Summary page 1.
- K071436: Regius Unitea, Konica Minolta Medical & Graphic, Inc. (2007) Summary page 1.

## Most influential descendants
- K133730: CO Pilot/Regius Unitea (2014), 2 descendants of its own
- K210066: ImagePilot (2021), 1 descendant of its own
- K240281: Bone Suppression Software (2024), 0 descendants of its own

## Indications for use
The Acies is a software product. It is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The Acies primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The Acies can process and display medical images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K101842
Methodology: https://510kreport.com/methodology