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
- [email protected]
- Phone
- 800 9341034 ext. 1427
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2007-10-31 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2020-06-26 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2015-01-16 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2015-01-16 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-12-26 |
| Full Field Digital, System, X-Ray, Mammographic | MUE | Class 2 | Radiology | No | 2012-01-05 |
| System, X-Ray, Stationary | KPR | Class 2 | Radiology | No | 2012-07-05 |
| Camera, Multi Format, Radiological | LMC | Class 2 | Radiology | No | 2008-12-08 |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | Class 1 | Clinical Chemistry | No | 2018-12-21 |
| Instrument, Quality-Assurance, Radiologic | LHO | Class 1 | Radiology | No | 2007-08-17 |
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)