FDA.reportPublic FDA data

MyLabX5

Primary DI
08056304453563
Brand
MyLabX5
Company
ESAOTE SPA
Model
102642004
Published
2019-06-13
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
K183191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1831910006420 Ultrasound SystemEsaote, S.p.A.2018-12-04IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056304453563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056304453563080563044535638056304453563

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
437384304
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056304454737Magnifico Open1000099002022-02-21
08056304455826MyLabC251007611002025-12-10
08056304455833MyLabC301007611202025-12-10
08056304450296MyLabSix CrystallLine1006425002016-11-29
08056304452597MyLabSeven 1016400022017-02-24
08056304452603MyLabEight eXP1016200302017-04-03
08056304452610MyLabEight1016250302017-04-03
08056304452658MyLab 9 eXP1006440002018-02-19
08056304452917C 1-81200000132018-02-19
08056304452924L 3-111200000142018-02-19
08056304452931P 1-51200000152018-02-19
08056304452948PA2501200000322018-02-19
08056304453037MyLabSix CrystaLine 1006425012017-02-24
08056304453068L 8-241200000372018-02-19
08056304453105L 4-151200000362018-02-19
08056304453150mC 3-111200000462018-02-19
08056304455017MyLabA501006610002025-07-07
080563044550622CWL1200001062025-07-07
080563044550795CWL1200001072025-07-07
08056304455215MyLabE851006450852025-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056304454386MyLabX75ESAOTE SPAIYO2021-09-24
08033737713037THD Procto Software SystemTHD SPAITX2021-07-19
08052461860046Echolight S.p.a.ECHOLIGHT SPAIYO2021-03-05
08056304454263MyLabSigma eliteESAOTE SPAIYN2020-10-23
08056304454263MyLabSigma eliteESAOTE SPAIYO2020-10-23
08056304453891E 3-12ESAOTE SPAITX2019-12-20
08056304454096C 2-9ESAOTE SPAITX2019-12-20
08056304453419MyLabX8ESAOTE SPAIYO2019-12-20
08056304453419MyLabX8ESAOTE SPAIYN2019-12-20
08056304454126MyLabX8 eXPESAOTE SPAIYN2019-12-20
08056304454126MyLabX8 eXPESAOTE SPAIYO2019-12-20
08056304453518MyLabX6ESAOTE SPAITX2019-06-13
08056304453518MyLabX6ESAOTE SPAIYN2019-06-13
08056304453525MyLabX7ESAOTE SPAITX2019-06-13
08056304453525MyLabX7ESAOTE SPAIYO2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYO2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYN2019-06-13
08056304453679MyLabSigmaESAOTE SPAIYO2019-06-13
08056304453679MyLabSigmaESAOTE SPAIYN2019-06-13
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