Konica Minolta Healthcare Americas, Inc.
Konica Minolta Healthcare Americas, Inc. holds FDA 510(k) medical device clearances, first cleared 2020, most recent 2026, with 2 FDA device recalls on record.
Top product codes for Konica Minolta Healthcare Americas, Inc.
FDA recalls by Konica Minolta Healthcare Americas, Inc.
- Z-0500-2022 — ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
- Z-0659-2019 — Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure Control, Collimator, Touch Screen Control and Image Receptor Assembly. The Positioner and the Patient Mobile Table are associated equipment to the Generator X-ray Unit.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Konica Minolta Healthcare Americas, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.