FDA.reportPublic FDA data

Ultrasound System SONIMAGE HS1

Primary DI
04560141945463
Brand
Ultrasound System SONIMAGE HS1
Company
KONICA MINOLTA, INC.
Model
A9RP
Published
2016-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162065000Ultrasound System SONIMAGE HS1Konica Minolta, Inc.2016-10-19IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560141945463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560141945463045601419454634560141945463

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
692076161
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560141951471ImagePilotV1.96R01E2026-04-24
04560141947719KONICAMINOLTA DI-X1AD1D2026-03-25
04560141950887P-53AEA02024-12-06
04560141950894P-53AEA12024-12-06
04560141945753P-61A8CE2017-01-04
04560141945821P-61A9YC2017-01-04
04560141950665DRYPRO SD-QM2AE6G2025-05-22
04560141950672DRYPRO SD-QM2AE6H2025-05-22
04560141950689DRYPRO SD-QM2AE6J2025-05-22
04560141951426CS-7AEVE2025-04-14
04560141951419CS-7AEVD2024-12-06
04560141951914KONICAMINOLTA DI-X1AEYC2024-10-07
04560141921788REGIUS MODEL 110JFF72016-09-19
04560141925557REGIUS MODEL 210A1YD2016-09-19
04560141925564REGIUS MODEL 110HQA1YC2016-09-19
04560141933170REGIUS MODEL SIGMAA1P62016-09-19
04560141933194REGIUS MODEL SIGMAA1P82016-09-19
04560141936379REGIUS MODEL SIGMA2A5ER2016-09-19
04560141936393REGIUS MODEL SIGMA2A5ET2016-09-19
04560141936423REGIUS MODEL SIGMA2A5EU2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953121382VolusonGE Ultrasound Korea Ltd.IYN2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08056304455017MyLabA50ESAOTE SPAIYO2025-07-07
08056304455215MyLabE85ESAOTE SPAIYO2025-07-07
08056304455307MyLabA70ESAOTE SPAIYO2025-07-07
08056304455437MyLabA50ESAOTE SPAIYO2025-07-07
08056304455451MyLabA70ESAOTE SPAIYO2025-07-07
08056304455635MyLabE80ESAOTE SPAIYO2025-07-07
08056304455642MyLabE85ESAOTE SPAIYO2025-07-07
08056304455628MyLabE80ESAOTE SPAIYO2024-03-29
08056304454980MyLabX90ESAOTE SPAIYO2023-12-14
08056304455031MyLabOmega eXPESAOTE SPAIYO2023-12-14
08056304455031MyLabOmega eXPESAOTE SPAIYN2023-12-14
08056304454676MyLabX9ESAOTE SPAIYN2023-06-13
G055ABMVIVM031VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM041VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM071VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM081VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM111VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM121VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVU010VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM010VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM020VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM050VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM060VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM090VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM100VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVR010VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30