SonicEye® Dual-Array Ultrasound System

Primary DI
00850012978008
Brand
SonicEye® Dual-Array Ultrasound System
Company
SONIVATE MEDICAL, INC.
Model
SDA-001
Device description
Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array.
Published
2020-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192253000SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.2020-02-25IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012978008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012978008008500129780088500129780080850012978008

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
301-498-4100inquire@sonivate.com
971-220-7871inquire@sonivate.com

Regulatory Flags#

DUNS number
135945496
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012978015GUISDA-0012020-06-10

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