FDA Registration Active 🇯🇵 Japan

KONICA MINOLTA TECHNOPRODUCTS CO., LTD.

Reg #: 3005406110 · FEI: 3005406110 · Expires 2026
Products
10
Proprietary Names
54
Establishment Types
2
Classifications
10

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Registration Details

Registration Name
KONICA MINOLTA TECHNOPRODUCTS CO., LTD.
Registration Number
3005406110
FEI Number
3005406110
Status
Active
Expiry Year
2026
Initial Importer
No
Address
2-2-1 HIROSEDAI
City
SAYAMA-SHI Saitama
Country
JP

Regulatory Submissions

510(k) Number
K071181

Owner / Operator

Firm Name
KONICA MINOLTA, INC.
Operator Number
9009884
Address
1 Sakura-machi
City
Hino-shi
State
Tokyo
Postal Code
191-8511
Country
JP
Correspondent
Taketoh Muraoka

US Agent

Business Name
Konica Minolta Healthcare Americas, Inc.
Contact Name
Jan Maniscalco
Address
411 Newark Pompton Turnpike
City
Wayne
State
NJ
ZIP
07470
Country
US
Phone
800 9341034 ext. 1427

Products

Device Name Product Code
Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
Transducer, Ultrasonic, Diagnostic ITX
System, Imaging, Pulsed Echo, Ultrasonic IYO
System, Imaging, Pulsed Doppler, Ultrasonic IYN
System, Image Processing, Radiological LLZ
Full Field Digital, System, X-Ray, Mammographic MUE
System, X-Ray, Stationary KPR
Camera, Multi Format, Radiological LMC
Bilirubin (Total And Unbound) In The Neonate Test System MQM
Instrument, Quality-Assurance, Radiologic LHO

Proprietary Names

REGIUS Cassette/Plate REGIUS Cassette REGIUS Plate REGIUS MODEL 110HQ REGIUS MODEL 110 KONICAMINOLTA DI-X1 AeroDR SYSTEM 2 CS-7 AeroDR P-52 Convex Probe C5-2 Linear Probe L11-3 Convex Probe MC10-3 Linear Probe L14-4 Ultrasound System SONIMAGE MX1 SKR 3000 P-61 P-81 P-71 Ultrasound Transducer 11M3 Model 11284923 Sector Probe S4-2 Ultrasound System SONIMAGE HS1 Endocavity Probe EC9-3 Linear Probe HL18-4 Ultrasound System SONIMAGE HS2 Linear Probe L18-4 AeroDR SYSTEM AeroDR P-31 ImagePilot P-65 P-75 G-59 G-60 G-22 REGIUS Plate FP-1S REGIUS Cassette RC-300 REGIUS SIGMA2 Xpress Digital Mammography System P-53 P-95 P-82 P-85 AeroDR Stitching system AeroDR P-51 Bone Suppression Software AeroDR P-21 Xpress Digital Mammography workstation ACIES AeroDR P-12 AeroDR P-11 AeroSync DRYPRO MODEL 873 REGIUS MODEL 210 REGIUS SIGMA Simple Check QC Phantom-2

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)