FDA.reportPublic FDA data

Achilles EXPII

Primary DI
00840682116978
Brand
Achilles EXPII
Company
GE Medical Systems (China) Co.,Ltd.
Model
v1
Device description
BONE ULTRASONOMETER, ACHILLES
Published
2016-06-27
Public version status
Update
Distribution status
Not 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
K103633000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103633000ACHILLESGe Medical Systems China Co., Ltd.2011-05-11MUA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682116978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682116978008406821169788406821169780840682116978

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature18 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654658731
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278644152N/ARAB7-DH48062AN2025-01-09
00195278783295Vividiq v2082025-03-06
00195278797551Vividiq v206 to v208 SW only upgrade kit2025-03-06
00195278796455VividT9 v2082025-03-06
00195278796462VividT8 v2082025-03-06
00195278797513Vividiq v206 to v208 HW and SW upgrade kit2025-03-06
00195278833570VividT8 T9 v206 to v208 SW only upgrade kit2025-03-06
00195278690401VersanaPremier LOTUS 4PP2024-11-20
00195278690418VersanaPremier LOTUS 5PP2024-11-20
00195278722430LOGIQLOGIQ F R32024-11-20
00195278690388VersanaPremier R3 VS2024-10-28
00195278690395VersanaPremier R3 VA2024-10-28
00195278466471NAL4-20t-DH48062AG2024-05-30
00195278674197LOGIQe TP2023-12-20
00195278674203LOGIQe TB2023-12-20
00195278300034VersanaBalance R2 VS2023-06-15
00195278300096VersanaBalance R2 VA2023-06-15
00195278503404VersanaEssential R2 VS2023-06-13
00195278503411VersanaEssential R2 VA2023-06-13
00840682190299NAL4-20t-RSH48062AJ2021-01-15

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
08052461860008Echolight S.p.a.ECHOLIGHT SPAMUA2019-11-25
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