FDA.report

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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions

SubmissionSupplement
K192253000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850012978008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012978008008500129780088500129780080850012978008

GMDN Terms

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

Contacts

PhoneEmail
301-498-4100inquire@sonivate.com
971-220-7871inquire@sonivate.com

Regulatory Flags

DUNS number
135945496
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

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