FDA.reportPublic FDA data

Echolight S.p.a.

Primary DI
08052461860046
Brand
Echolight S.p.a.
Company
ECHOLIGHT SPA
Model
EchoStudio
Published
2021-03-05
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
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
MUABone Sonometer
OMVUltrasonic Body Composition Analyzer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
MUABone SonometerRadiology2
OMVUltrasonic Body Composition AnalyzerCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202514000EchoS FamilyEcholight S.P.A2021-02-25MUA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052461860046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052461860046080524618600468052461860046

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical body composition analyserAn electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.

Sterilization Methods#

Method table
Method

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
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
08052461860008Echolight S.p.a.EchoS2019-11-25
08052461860015Echolight S.p.a.EchoStation2019-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06948941160022Bladder ScannerMeda Co., LtdIYO2026-10-08
00855683006821AquaflexPARKER LABORATORIES INCIYO2026-10-01
00855683006845AquaflexPARKER LABORATORIES INCIYO2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.IYO2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.IYO2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYO2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYO2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
08809887550125EdgeFlow UH10SEdgeCare Inc.IYO2026-06-19
08809887550132EdgeFlow UH10LEdgeCare Inc.IYO2026-06-19