FDA.reportPublic FDA data

SonoScape

Primary DI
06945868614003
Brand
SonoScape
Company
SONOSCAPE MEDICAL CORP.
Model
S40
Device description
S40 Digital Color Doppler Ultrasound System
Published
2016-08-19
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
K150045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150045000S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited2015-04-28IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945868614003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945868614003069458686140036945868614003

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

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
08033737713037THD Procto Software SystemTHD SPAITX2021-07-19
08052461860046Echolight S.p.a.ECHOLIGHT SPAIYO2021-03-05
08056304454263MyLabSigma eliteESAOTE SPAIYO2020-10-23
08056304453891E 3-12ESAOTE SPAITX2019-12-20
08056304454096C 2-9ESAOTE SPAITX2019-12-20
08056304453419MyLabX8ESAOTE SPAIYN2019-12-20
08056304453419MyLabX8ESAOTE SPAIYO2019-12-20
08056304454126MyLabX8 eXPESAOTE SPAIYO2019-12-20
08056304454126MyLabX8 eXPESAOTE SPAIYN2019-12-20
08056304453518MyLabX6ESAOTE SPAIYN2019-06-13
08056304453518MyLabX6ESAOTE SPAITX2019-06-13
08056304453525MyLabX7ESAOTE SPAITX2019-06-13
08056304453525MyLabX7ESAOTE SPAIYO2019-06-13
08056304453563MyLabX5ESAOTE SPAITX2019-06-13
08056304453563MyLabX5ESAOTE SPAIYO2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYO2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYN2019-06-13
08056304453679MyLabSigmaESAOTE SPAIYN2019-06-13
08056304453679MyLabSigmaESAOTE SPAIYO2019-06-13
08056304453921MyLab 9ESAOTE SPAITX2019-06-13
08056304453921MyLab 9ESAOTE SPAIYN2019-06-13
08056304452658MyLab 9 eXPESAOTE SPAITX2018-02-19
08056304452658MyLab 9 eXPESAOTE SPAIYN2018-02-19
08056304452603MyLabEight eXPESAOTE SPAIYO2017-04-03
08056304452603MyLabEight eXPESAOTE SPAIYN2017-04-03
08056304452610MyLabEightESAOTE SPAITX2017-04-03
08056304452610MyLabEightESAOTE SPAIYO2017-04-03
08056304452597MyLabSeven ESAOTE SPAITX2017-02-24
08056304452597MyLabSeven ESAOTE SPAIYO2017-02-24
08056304453013MyLabOneEsaote Europe B.V.IYO2017-02-24