# K210066: ImagePilot

- Pathway: 510(k) (Special)
- Applicant: Konica Minolta, Inc.
- Decided: May 6, 2021 after 115 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913770 (1991). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071436: Regius Unitea, Konica Minolta Medical & Graphic, Inc. (2007) Summary page 4.
- K133730: CO Pilot/Regius Unitea, Konica Minolta, Inc. (2014) Summary page 4.

## Most influential descendants
- K240281: Bone Suppression Software (2024), 0 descendants of its own

## Recalls of this device
- Dec 3, 2021 · Class II · Z-0500-2022: lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed

## Indications for use
The ImagePilot software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The ImagePilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The ImagePilot software can process and display medical images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The ImagePilot must not be used for primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K210066
Methodology: https://510kreport.com/methodology