FDA.reportPublic FDA data

Clarius Ultrasound Scanner

Primary DI
07540205000861
Brand
Clarius Ultrasound Scanner
Company
Clarius Mobile Health Corp
Model
Clarius Cart
Catalog number
99-02-00039; 50-02-00033; 50-02-00039
Device description
Mobile cart with multi-port battery charger
Published
2019-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180799000Clarius Ultrasound ScannerClarius Mobile Health Corp.2018-05-14IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540205000861Direct MarkingGS10
07540205000854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540205000861075402050008617540205000861
07540205000854075402050008547540205000854

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
202522751
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540205001356Clarius Ultrasound Scanner Clarius Scanner PAL HD399-13-00029, 99-02-000852024-02-01
07540205000397Clarius Ultrasound ScannerApp - iOS12-01-000032017-04-25
07540205000403Clarius Ultrasound ScannerApp - Android12-01-000042017-04-25
07540205000168Clarius Ultrasound ScannerBattery99-02-000012017-04-25
07540205000335Clarius Ultrasound ScannerBattery - ARTHREX80-02-00001; AR-3500-01B2017-04-25
07540205001196Clarius Ultrasound Scanner Clarius Scanner L7 HD399-13-00020, 99-02-000772022-09-29
07540205001202Clarius Ultrasound Scanner Clarius Scanner C7 HD399-13-00019, 99-02-000752022-09-29
07540205001219Clarius Ultrasound Scanner Clarius Scanner EC7 HD399-13-00024, 99-02-000762022-09-29
07540205001226Clarius Ultrasound Scanner Clarius Scanner L15 HD399-13-00021, 99-02-000782022-09-29
07540205001233Clarius Ultrasound Scanner Clarius Scanner PA HD399-13-00023, 99-02-000802022-09-29
07540205001240Clarius Ultrasound Scanner Clarius Scanner L20 HD399-13-00022, 99-02-000792022-09-29
07540205001349Clarius Ultrasound Scanner Clarius Charger HD399-13-00030, 99-03-000232022-09-29
07540205001189Clarius Ultrasound Scanner Clarius Scanner C3 HD399-13-00018, 99-02-000742022-09-29
07540205001271Clarius Ultrasound Scanner Clarius Scanner L7 HD399-13-00020, 99-02-000772022-09-29
07540205001288Clarius Ultrasound Scanner Clarius Scanner C7 HD399-13-00019, 99-02-000752022-09-29
07540205001295Clarius Ultrasound Scanner Clarius Scanner EC7 HD399-13-00024, 99-02-000762022-09-29
07540205001301Clarius Ultrasound Scanner Clarius Scanner L15 HD399-13-00021, 99-02-000782022-09-29
07540205001318Clarius Ultrasound Scanner Clarius Scanner PA HD399-13-00023, 99-02-000802022-09-29
07540205001325Clarius Ultrasound Scanner Clarius Scanner L20 HD399-13-00022, 99-02-000792022-09-29
07540205001363Clarius Ultrasound Scanner Clarius Charger HD399-13-00030, 99-03-000232022-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027419LA2-9SDSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290028638CA2-8ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029390EV2-10ASAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029420CV1-8AESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.ITX2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08800289979132cV4 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
08800289970351cV8 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-02-27