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KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

Last updated May 24, 2026

What KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. makes

The company manufactures digital x-ray imaging solutions, including stationary and portable x-ray systems designed for basic diagnostic use. Their portfolio includes indirect flat panel detectors, digital imaging cassettes, and workstation software for processing and viewing radiographic images. Examples include wireless flat panel detectors, portable detector systems, and specialized sensor panels for various imaging applications.

These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates primarily in the United States, adhering to U.S. regulatory standards for medical imaging equipment.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Konica Minolta Medical Imaging U.S.A., Inc. manufacture?

Konica Minolta Medical Imaging U.S.A., Inc. specializes in digital x-ray imaging solutions. Their product portfolio includes stationary and portable basic diagnostic x-ray systems, indirect flat panel detectors (like wireless and fixed detectors), digital imaging cassettes, and workstation software for processing and viewing radiographic images. These devices are designed to enhance diagnostic imaging workflows in clinical settings.

Where is Konica Minolta Medical Imaging U.S.A., Inc. based, and what regulatory standards do they follow?

The company is based in the United States. Since their devices are intended for the U.S. market, they adhere to U.S. regulatory standards, including those set by the FDA. Their products fall under the FDA’s classification system, ensuring compliance with requirements for medical imaging equipment.

Which regulatory registries or databases list Konica Minolta Medical Imaging U.S.A., Inc.’s devices?

Konica Minolta Medical Imaging U.S.A., Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices, ensuring transparency and traceability in regulatory oversight. This listing applies to their Class II devices, which require compliance with specific FDA regulations.

How are Konica Minolta Medical Imaging U.S.A., Inc.’s devices classified under FDA regulations?

Konica Minolta Medical Imaging U.S.A., Inc.’s devices are classified as Class II under FDA regulations. This classification applies to most of their digital x-ray imaging solutions, including portable and stationary systems, detectors, and software. Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: konicaminolta.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-800-366-5343
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 080269345

Catalogue (45)

Device	Model / Reference	Registries	Class	Status
3543EZ CsI Digital Wireless Flat Panel Detector	PAN280	FDA UDI	Class II	Active
14X17 Portable GOS Flat Panel Detector	PAN240	FDA UDI	Class II	Active
Konica Minolta SW (Acquire) Opal, 20/20 Opal (Acquire) Vizion	OPALACQ 04-02-01-000	FDA UDI	Class II	Active
RF 11X14 Sensor Panel	PAN291	FDA UDI	Class II	Active
Advanced Universal U-Arm Stand 4000	XR3500B	FDA UDI	Class II	Active
17X17 GOS Fixed Flat Panel Detector	PAN221	FDA UDI	Class II	Active
U-Arm System	XR3000	FDA UDI	Class II	Active
Portable X-Ray System	XR310	FDA UDI	Class II	Active
1717 Flat Panel Detector	PAN253	FDA UDI	Class II	Active
10X12 Cassette for CR Reader	CASCR2430	FDA UDI	Class II	Active
2020i Imaging Hand System	XR420i	FDA UDI	Class II	Active
Konica Minolta SW (PACS) Exa	EXA 01-04-000	FDA UDI	Class II	Active
14X17 Portable GOS Flat Panel Detector without USB	PAN241	FDA UDI	Class II	Active
14X17 Wireless GOS Flat Panel Detector	PAN200	FDA UDI	Class II	Active
Konica Minolta Software Opal Acquire	OPALACQ-02-03-04-000	FDA UDI	Class II	Active
Portable X-Ray System	XR301	FDA UDI	Class II	Active
KDR DDR Primary U Arm	Primary	FDA UDI	Class II	Active
U-Arm System Basic	XR3001	FDA UDI	Class II	Active
Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad	OPAL 02-04-06-000	FDA UDI	Class II	Active
Flat Panel Detector	PAN262	FDA UDI	Class II	Active
Millenium Floor Mounted Tube Stand	XR100	FDA UDI	Class II	Active
4143C CsI Compact Digital Flat Panel Detector	PAN261	FDA UDI	Class II	Active
Konica Minolta SW Opal (Acquire), 20/20 Opal (Acquire)	OPALACQ-04-01-00-000	FDA UDI	Class II	Active
Dynamic DR Room	RF6000	FDA UDI	Class II	Active
Overhead Tube Crane Ceiling Suspension	XR5100	FDA UDI	Class II	Active
14X17 Flat Panel Detector	PAN251	FDA UDI	Class II	Active
Konica Minolta Software Opal Acquire	OPALACQ-02-04-00-000	FDA UDI	Class II	Active
2020 Imaging Podiatry System	XR400i	FDA UDI	Class II	Active
17X17 CsI Fixed Flat Panel Detector	PAN220	FDA UDI	Class II	Active
CR Reader	CRII60	FDA UDI	Class II	Active
2020i Straight Arm	XR1000i	FDA UDI	Class II	Active
CR Reader	CR30	FDA UDI	Class II	Active
Konica Minolta SW (Acquire) Ultra	ULTRA 04-02-01-000	FDA UDI	Class II	Active
Overhead Tube Crane	XR5200	FDA UDI	Class II	Active
Advanced Universal U-Arm Stand 3000	XR3002	FDA UDI	Class II	Active
Konica Minolta Ultra Software	ULTRA 04-01-00-000	FDA UDI	Class II	Active
2020 Imaging Podiatry System HF	XR410i	FDA UDI	Class II	Active
RF 11X14 Sensor Panel	PAN292	FDA UDI	Class II	Active
1717 Flat Panel Detector	PAN252	FDA UDI	Class II	Active
Straight Arm System	XR1000	FDA UDI	Class II	Active
4343 CsI Digital Flat Panel Detector	PAN260	FDA UDI	Class II	Active
Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad	OPAL 02-04-04-000	FDA UDI	Class II	Active
Portable X-Ray System	XR300	FDA UDI	Class II	Active
14X17 Cassette for CR Reader	CASCR3543	FDA UDI	Class II	Active
RF 14X17 Sensor Panel	PAN290	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Konica Minolta Medical Imaging U.S.A., Inc. has nine recall records initiated between February 6, 2006, and May 9, 2018, all of which are marked as terminated. The reasons cited include potential battery ignition risks in laptops used in product configurations, mechanical malfunctions such as a hand grip column shifting unexpectedly during patient use, circuit board breakage in AC adapters with possible smoke emission, data entry errors causing demographic fields to auto-populate with previous patient information, and overheating of power supplies in Japan leading to smoke and minor flame occurrences.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 9, 2018	Z-2282-2018	—	terminated	Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignition (fire) in CF-C2 "Toughbook" laptops. Since Konica Minolta uses this laptop in some of its product configurations, it notified its customers to utilize a BIOS Utility for the laptops to minimize the risk of an incident while Panasonic develops a final solution.
May 9, 2018	Z-2281-2018	—	terminated	Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignition (fire) in CF-C2 "Toughbook" laptops. Since Konica Minolta uses this laptop in some of its product configurations, it notified its customers to utilize a BIOS Utility for the laptops to minimize the risk of an incident while Panasonic develops a final solution.
Dec 4, 2017	Z-1215-2018	—	terminated	There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.
Dec 4, 2017	Z-1214-2018	—	terminated	There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.
Dec 4, 2017	Z-1212-2018	—	terminated	There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.
Dec 4, 2017	Z-1213-2018	—	terminated	There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.
Oct 6, 2006	Z-0220-2007	—	terminated	The power supply of a unit located in Japan overheated and caused a smoke condition and a small amount of flame coming off the unit.
Jul 14, 2006	Z-1481-06	—	terminated	A hand grip column, even though locked in position, moved downward about 3 cm while a patient was holding the hand grip for lateral exposure. When the hand grip moved down, the patient who was holding it lost his or her balance and almost fell. This problem only occurred in Japan with one system.
Feb 6, 2006	Z-0862-06	—	terminated	If the patient demographic data is entered into the CS-1 manually, and the user fails to enter any data in one of the demographic data fields labeled as Birthday, Sex, Name or Patient Comments, etc, the RIM will populate the fields where no data has been entered with data from the previous patient.