FDA.reportPublic FDA data

Clarius Ultrasound Scanner

Primary DI
07540205000328
Brand
Clarius Ultrasound Scanner
Company
Clarius Mobile Health Corp
Model
C3-60 Premium
Catalog number
99-02-00018; 50-02-00004
Published
2017-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163138000Clarius Ultrasound SystemClarius Mobile Health Corp.2016-11-30IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540205000083Direct MarkingGS10
07540205000328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540205000083075402050000837540205000083
07540205000328075402050003287540205000328

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held ultrasound imaging system, body-surfaceA battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.

Regulatory Flags#

DUNS number
202522751
Device count
1
Serial number
true
No natural rubber latex
true

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

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Primary DI, Brand, Company table
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00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
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00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYN2026-07-24
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