Konica Minolta, Inc.
Garner, NC, US
KONICA MINOLTA, INC. appears in FDA device records in Garner, NC. FDA records list 31 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 14 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Konica Minolta, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Konica Medical Imaging, Inc.recall
- Konica Minolta Healthcare Americas, Incregistration, 510(k), enforcement report, recall
- Konica Minolta Medical Imaging USA, Inc.enforcement report, recall
510(k) clearance history
FDA records hold 31 510(k) clearances for Konica Minolta, Inc. between 2014 and 2026. The busiest year on record is 2022, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 4 |
| 2022 | 6 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252996 | Universal 1417PI | MQB | Substantially Equivalent | |
| K250665 | SKR 3000 | MQB | Substantially Equivalent | |
| K241319 | SKR 3000 | MQB | Substantially Equivalent | |
| K240281 | Bone Suppression Software | LLZ | Substantially Equivalent | |
| K230906 | Konicaminolta DI-X1 | LLZ | Substantially Equivalent | |
| K223267 | SKR 3000 | MQB | Substantially Equivalent | |
| K221853 | OTC DDR | KPR | Substantially Equivalent | |
| K220993 | Ultrasound System SONIMAGE MX1 | IYN | Substantially Equivalent | |
| K213908 | SKR 3000 | MQB | Substantially Equivalent | |
| K214030 | Universal DR 1748 | MQB | Substantially Equivalent | |
| K214012 | Straight Arm DDR | KPR | Substantially Equivalent | |
| K203743 | EXA | LLZ | Substantially Equivalent | |
| K212685 | KONICAMINOLTA DI-X1 | LLZ | Substantially Equivalent | |
| K210619 | SKR 3000 | MQB | Substantially Equivalent | |
| K210066 | ImagePilot | LLZ | Substantially Equivalent | |
| K193225 | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography | KPR | Substantially Equivalent | |
| K191645 | SKR 4000 | MQB | Substantially Equivalent | |
| K182688 | SKR 3000 | MQB | Substantially Equivalent | |
| K182431 | Konicaminolta DI-X1 | LLZ | Substantially Equivalent | |
| K182153 | Ultrasound System SONIMAGE HS1 | IYO | Substantially Equivalent | |
| K180084 | Ultrasound System SONIMAGE MX1 | IYO | Substantially Equivalent | |
| K172793 | SKR 3000 | MQB | Substantially Equivalent | |
| K171716 | SKR 3000 | MQB | Substantially Equivalent | |
| K162065 | Ultrasound System SONIMAGE HS1 | IYN | Substantially Equivalent | |
| K162504 | SKR 3000 | MQB | Substantially Equivalent | |
| K152577 | ULTRASOUND SYSTEM SONIMAGE HS 1 | IYN | Substantially Equivalent | |
| K151465 | AeroDR SYSTEM 2 | MQB | Substantially Equivalent | |
| K151060 | Ultrasound System SONIMAGE HS1 | IYO | Substantially Equivalent | |
| K142197 | ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 | IYN | Substantially Equivalent | |
| K141271 | AERODR SYSTEM 2 | MQB | Substantially Equivalent | |
| K133730 | CO PILOT/REGIUS UNITEA | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003769120 | 3003769120 | KONICA MINOLTA, INC. | 2970 ISHIKAWA-MACHI, HACHIOJI-SHI Tokyo 192-8505 JP | 2026 | |
| 3004485675 | 3004485675 | KONICA MINOLTA, INC. | 1 SAKURA-MACHI, HINO-SHI Tokyo 191-8511 JP | 2026 | |
| 1064396 | 3002885429 | Konica Minolta Healthcare Americas, Inc | 2217 Us Highway 70 E, Garner, NC 27529 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LMCCamera, Multi Format, Radiological
- IWZFilm, Radiographic
- MUEFull Field Digital, System, X-Ray, Mammographic
- LHOInstrument, Quality-Assurance, Radiologic
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- KPRSystem, X-Ray, Stationary
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 | 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 | Class II | Terminated | |
| 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. | Unintentional U-Arm movement | Class II | Terminated | |
| Z-2282-2018 | ImagePilot, Model No. D9MA | 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. | Class II | Terminated | |
| Z-2281-2018 | CS-7, Model No. A4C1 | 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. | Class II | Terminated | |
| Z-1215-2018 | Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588 | 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. | Class II | Terminated | |
| Z-1214-2018 | Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470 | 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. | Class II | Terminated | |
| Z-1213-2018 | Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534 | 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. | Class II | Terminated | |
| Z-1212-2018 | Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031 | 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. | Class II | Terminated | |
| Z-2769-2017 | Diagnostics Ultrasound System Ultrasounds System Sonimage HS1 | The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate. | Class II | Terminated | |
| Z-0220-2007 | Konica Minolta PrintLink III Model - ID/IV, code no. 0770, 0771 Medical Imaging Communication Device Model IV - product code 5000230 Model ID, product code 5000330 Konica Minolta Medical & Graphic, Inc. No. 26-2, Nishishinjuku 1-chrome, Shinjuku-ku, Tokoyo 163-0512, Japan | 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. | Terminated | ||
| Z-1481-06 | Regius Model 370 Digital Radiography Konica Minolta | 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. | Terminated | ||
| Z-0862-06 | REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technologist review and audit. Key processing for specialized exams, totally automated processing for hands off operation. Centralized workflow device for dispersed readers environments. HIS/RIS patient status updates. Demographic Correction. | 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. | Terminated | ||
| Z-1391-05 | Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software. | One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly. | Terminated | ||
| Z-0150-04 | Konica Minolta Duplicating Film Emulsions. Konica Medical Film. Emulsion numbers X(=any number), X 742, X842, X152. Film type SR-DUP 8x10, 10x12, 11x14, and 14x17. Film type PPD DUP 10x12 only and Emulsion Number X152. SR-DUP C 14x17 Emulsion X023 only. | Loss of detail at density of 1.00 to 2.00, on certain bony structures found in original clinical films. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain