FDA.reportPublic FDA data

FibroScan

Primary DI
03662264000072
Brand
FibroScan
Company
ECHOSENS
Model
XL+
Published
2016-09-23
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123806000
K150949000
K160524000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123806000FIBROSCANEchosens2013-04-05IYO
K150949000FibroScanEchosens2015-06-03IYO
K160524000FibroScan 530 CompactEchosens2016-03-18IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662264000072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662264000072036622640000723662264000072

GMDN Terms#

Term, Definition table
TermDefinition
Hepatic ultrasound elastography system applicatorA non-sterile hand-held device designed to be used for the transcutaneous measurement of liver stiffness based on transient elastography. It includes an ultrasound transducer and an electrodynamic transducer intended to generate a controlled transient vibration that produces a mechanical elastic shear wave propagated through the skin and liver; subsequent ultrasound measurements can be used to calculate a measure of liver stiffness/ultrasonic attenuation of tissues. The device is designed to connect to a control unit and may be available in various forms for different applications [e.g., paediatric, bariatric (obese)]. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure54 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
571069108
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662264001222FibroScanFibroScan 2302021-08-27
03662264001161FibroScanFibroScan 6302020-09-11
03662264001185FibroScanFibroScan 530 Compact2019-03-05
03662264001208FibroScanFibroScan 430 MINI+2019-03-05
03662264000058FibroScanM+2016-09-23
03662264000065FibroScanS+2016-09-23
03662264001031FibroScanFibroScan 502 Touch2016-09-23
03662264001048FibroScanFibroScan 502 Touch2016-09-23
03662264001062FibroScanFibroScan 530 Compact2016-09-23
03662264001147FibroScanFibroScan 430 MINI+2017-11-06

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