Echolight S.p.a.

Primary DI
08052461860008
Brand
Echolight S.p.a.
Company
ECHOLIGHT SPA
Model
EchoS
Published
2019-11-25
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
MUABone Sonometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUABone SonometerRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180516000EchoSEcholight S.P.A2018-10-19MUA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052461860008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052461860008080524618600088052461860008

GMDN Terms#

Term, Definition table
TermDefinition
Bone absorptiometric ultrasound systemAn assembly of devices used to produce bone density measurements and other calculations based on data obtained from transmitted and reflected ultrasound (US) waves. Also called a bone densitometer, it has an integrated ultrasound transducer to deliver an ultrasound beam to an anatomical region of interest. Information obtained from detection and analysis of resulting echoes is used in calculations to estimate bone mineral density or subcutaneous fat, or to make other quantitative assessments (e.g., fracture risk). It typically incorporates an ultrasound transducer, detection electronics, a control panel, a computer, software programs, a video display, and a patient positioning system (PPS).

Regulatory Flags#

DUNS number
431139071
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052461860046Echolight S.p.a.EchoStudio2021-03-05
08052461860091Echolight S.p.a.OsteoStudio2025-04-09
08052461860053Echolight S.p.a.EchoStation2025-04-09
08052461860060Echolight S.p.a.OsteoS2025-04-09
08052461860084Echolight S.p.a.OsteoStation2025-04-09
08052461860022Echolight S.p.a.EchoS2021-03-04
08052461860039Echolight S.p.a.EchoStation2021-03-04
08052461860015Echolight S.p.a.EchoStation2019-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052461860053Echolight S.p.a.ECHOLIGHT SPAMUA2025-04-09
08052461860060Echolight S.p.a.ECHOLIGHT SPAMUA2025-04-09
08052461860084Echolight S.p.a.ECHOLIGHT SPAMUA2025-04-09
08052461860091Echolight S.p.a.ECHOLIGHT SPAMUA2025-04-09
06430065790068Bindex BI-2 KitBone Index Finland OyMUA2024-02-01
08052461860046Echolight S.p.a.ECHOLIGHT SPAMUA2021-03-05
08052461860022Echolight S.p.a.ECHOLIGHT SPAMUA2021-03-04
08052461860039Echolight S.p.a.ECHOLIGHT SPAMUA2021-03-04
08052461860015Echolight S.p.a.ECHOLIGHT SPAMUA2019-11-25
06430065790051Bindex BI-2 KitBone Index Finland OyMUA2018-01-03
06430065790037Bindex BI-2 KitBone Index Finland OyMUA2017-05-31
06430065790044Bindex BI-2 KitBone Index Finland OyMUA2017-05-31
07290012704109BeamMedBEAMMED LTDMUA2017-01-25
07299012704119BeamMedBEAMMED LTDMUA2017-01-25
06430065790006BindexBone Index Finland OyMUA2017-01-16
06430065790013BindexBone Index Finland OyMUA2017-01-16
00840682116978Achilles EXPIIGE Medical Systems (China) Co.,Ltd.MUA2016-06-27