FDA.reportPublic FDA data

SonoScape

Primary DI
06945868602451
Brand
SonoScape
Company
SONOSCAPE MEDICAL CORP.
Model
VE3-10
Device description
VE3-10 Ultrasonic Transducer (P50)
Published
2018-08-28
Public version status
New
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
K170999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170999000P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.2017-07-12IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945868602451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945868602451069458686024516945868602451

GMDN Terms#

Term, Definition table
TermDefinition
Rectal/vaginal ultrasound imaging transducerAn invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545342185
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945868603434SonoScapeEG-550L2022-04-07
06945868603441SonoScapeEC-5502022-04-07
06945868603458SonoScapeEC-550T2022-04-07
06945868603465SonoScapeEC-550L2022-04-07
06945868603540SonoScapeHD-550Exp2022-04-07
06945868603557SonoScapeHD-550Pro2022-04-07
06945868603564SonoScapeHD-550S2022-04-07
06945868603571SonoScapeHD-5102022-04-07
06945868603588SonoScapeHD-500Plus2022-04-07
06945868603601SonoScapeVLS-55Q2022-04-07
06945868603618SonoScapeVLS-55T2022-04-07
06945868603854SonoScapeVLS-51T2022-04-07
06945868603861SonoScapeVLS-51D2022-04-07
06945868605155SonoScapeHD-5502022-04-07
06945868605193SonoScapeEC-550L/T2022-04-07
06945868605186SonoScapeEG-5502022-04-07
06945868610135SonoScapeX11 Exp2025-12-17
06945868610142SonoScapeX11 Elite2025-12-17
06945868610159SonoScapeX11 Pro2025-12-17
06945868610166SonoScapeX11 Plus2025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.IYO2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.IYN2026-06-23
00841517112646L15-4FUJIFILM SONOSITE, INC.IYO2026-06-23
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.IYN2026-06-22
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
00841517112639L12-3FUJIFILM SONOSITE, INC.IYO2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10