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GE Healthcare
EC Declaration of Conformity Lunar iDXA
DOC0108452
EC DECLARATION OF CONFORMITY
(Following the provisions of the medical devices directive 93/42/EEC, Annex II and of the directive 2011/65/EU)
We EU Authorized Representative
GE Medical Systems SCS
GEHC Manufacturer 283 rue de la Miniére
GE Medical Systems Ultrasound &
Primary Care Diagnostics LLC 78530 BUC, France
3030 Ohmeda Drive
Madison, Wisconsin, 53718, USA
GEHC Manufacturing site:
* GE MEDICAL SYSTEMS MONTERREY, MEXICO S.A. de C.V
Calle Espana #300, Parque Industrial Huinala, Apodaca, NL 66645, Mexico
Declare under our sole responsibility that the class IIb device:
Lunar iDXA
X-Ray Bone Densitometer System
Ref.: See addendum of this EC Declaration of Conformity
GMDN Code: 37661 UDI-DI Code: 00840682117029
Classification rule (93/42/EC Annex IX): 10 Class IIb
To which this declaration relates, is in conformity with the requirements of the medical device directive 93/42/EEC
which apply to it and with the requirements of the directive 2011/65/EU on the restriction of the use of certain
hazardous substances in electrical and electronic equipment.
This conformity is based on the follawing elements:
- For the directive 93/42/EEC (MDD)
o Technica! Documentation/DHF Ref./ réf: DOC0667694, of the product to which this declaration
relates
o EC Certificate: full quality assurance system (Annex II of the medical devices directive 93/42 EEC)
delivered by TUV Rheinland LGA Products GmbH (Notified Body n° 0197) on 10-01-2020/
Certificate N° HD 60143885 0001
o harmonized standards applied on the product to which this declaration relates
EN 60601-1: 2006A1:2013 EN 60601-2-28: 2010 EN 62366: 2008
EN 60601-1-2: 2015 EN 60601-1-3: 2008 A11:2016 EN ISO 10993-1: 2009 AC: 2010
EN ISO 14155: 2020 EN 60601-1-8: 2007 A11:2017 EN ISO 15223-1: 2016
EN 60601-1-6: 2010 EN ISO 10993-5: 2009 EN 1041: 2008
EN 62304: 2006 AC: 2008
- For the directive 2011/65/EU (RoHS)
o Technical Documentation/DHF Ref./ réf: DOC0667694, of the product to which this declaration
relates
Date of issue: 15-June-2023
Place of issue:
St. Louis MA
Name:
Function: Product Regulatory Affairs Leader
This version supersedes the previous version dated 31-January-2023.
Page 1 Declaration: D0C0108452 (Rev 43)
GE Healthcare
EC Declaration of Conformity Lunar iDXA (46)
DOC0108452
ADDENDUM TO THE EC DECLARATION OF CONFORMITY
Category Catalog Product Description
Number
X-Ray Bone H8930BF Lunar iDXA (assembled in Mexico)
Densitometer Lunar iDXA (assembled in Mexico for Mainland China only)
H8930BG
Included components covered by X-Ray Bone Densitometer System and non-medical devices / components:
H8940AZ enCORE v18SP5 W10 Prod/iDXA
H8950AZ enCORE v18SP5 W10 Prod/iDXA IB
H8940AY enCORE v18SP4/4.1 W10 Prod/iDXA
H8950AY enCORE v185P4/4.1 W10 Prod/iDXA IB
H8940AX enCORE v18SP3 W10 Prod/iDXA
H8950AX enCORE v18SP3 W10 Prod/iDXA IB
H8940AW enCORE v18SP2 W10 Prod/iDXA
H8950AW enCORE v18SP2 W10 Prod/iDXA IB
H8940AQ enCORE 18 SP1 (Windows 10 Prodigy, iDXA IB)
enCORE 18 SP1 IB (Windows 10 Prodigy, iDXA IB)
H8950AQ, enCORE 18 (Windows 10 Prodigy, iDXA IB)
H8940AK enCORE 18 IB (Windows 10 Prodigy, iDXA IB)
H8950AK enCORE v17SP6 (Windows 10 Prodigy, iDXA)
H8940BA enCORE v17SP6 IB (Windows 10 Prodigy, iDXA IB)
H8950BA enCORE v17SP6 IB (Windows 7 Prodigy, iDXA IB)
H8950BB enCORE v17SP5 (Windows 10 Prodigy, iDXA)
H8940AS enCORE v17SP5 IB (Windows 10 Prodigy, iDXA IB)
H8950AS enCORE v17SP5 [B (Windows 7 Prodigy, iDXA IB)
H8950AT enCORE v17SP5 (Windows 7 Prodigy, iDXA )
H8940AT
H8940AN enCORE 17SP4
H8950AN enCORE 17SP4 IB
Software H8940AH enCORE 17SP2
H8950AH enCORE 17SP2 IB
H8940AE enCORE 17SP1
H8950AE enCORE 17SP1 IB
H8940AM enCORE 16SP4
H8950AM enCORE 16SP4 IB
H8940AJ enCORE 16SP3
enCORE 16SP3 IB
H8950AJ enCORE 15SP4
H8600AL
H8650KK enCORE 15SP4 IB
H8600AC enCORE 14.1
H8650KC enCORE 14.1 1B
Page 2 * Printed copies are uncontrolled unless otherwise identified * DOC0108452 (Rev 43)
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GE Healthcare Confidential
GE Healthcare
EC Declaration of Conformity Lunar iDXA
DOC0108452
ADDENDUM TO THE EC DECLARATION OF CONFORMITY
Category Catalog Product Description
Number
enCORE 13.6
H8600AB enCORE 13.6 !B
H8650KB
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GE Healthcare
EC Declaration of Conformity Lunar iDXA
DOC0108452
H8920AQ, Global PC W10 Prodigy/iDXA-USA (LU45691-USA)
H8920AR Global PC W10 Prodigy/iDXA-ROW (LU45692-ROW)
H8910BB
Computer Global PC - ; USA
(mandatory)
Computer Monitors* iDXA
Scan Modes H8910BE Global PC - iDXA
H8920AX
Analysis Reporting Global PC W10 - Lenovo W10 2021
H8625LW 20" 16x9 Aspect (Global Monitor with NEMA cord)
H8910MA 24" Monitor Prodigy/iDXA/NT
H8910MC 24" Monitor for Prodigy, iDXA, DPX
H8910MD 24" Monitor for Prodigy, iDXA, DPX
H8910ME 24" Monitor Prodigy/ iDXA
H8910MF 24" Monitor Prodigy/ iDXA
*Non-GEHC Computer Monitor can be locally sourced using specifications described in DXA
with enCORE User Manual LU43616.
H8650AT AP Spine
H8650FE Femur
H8650DF Dual Femur
H8970AF AFF (Atypical Femur Fracture)
H8650AH AHA (Advanced Hip Analysis)
H8650SC One Scan
H8650TS Ouick View
H8650TB Total Body BMD
H8650BC Body Comp
H8801AB Advanced Body Composition
H8801CS iDXA Visceral Adipose Tissue (VAT)
H8650FA Forearm
H8650SF Non Seated Forearm
H8650DM iDXA DVA (Includes: LVA, APVA, Lateral BMD)
H8650MH Orthopedic Hip
H8650KN Orthopedic Knee
H8950KN Orthopedic Knee w Positioner
H8650PD Pediatric
H8650HB Pediatric - Total Body
H8650HC Pediatric - AP Spine
H8650PF Pediatric Femur
H8650P Complete Peds
H8650HA Hand
H8650GM Spine Geometry
H8609SA Small Animal
H8650LH Adult TBLH
Page 4 * Printed copies are uncontrolled unless otherwise identified * DOC0108452 (Rev 43)
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EC Declaration of Conformity Lunar iDXA
DOC0108452
Connectivity H8650AN Advanced Analytics Body Comp
PMT H8650AB Advanced Analytics Bone
H8650AV Advanced Analytics Full
USB Keyboards H8650VS DXAVision
H8650D DVO
Power Cord for PC and H8650F FRAX
Monitor H8650BS Integrated TBS (Includes TBS license)
H8650BD Integrated TBS Demo (includes TBS Demo license)
H8650BU Integrated TBS Upgrade from TBS Insight v3.0 (during warranty)
Integrated TBS IB
H8650BW
H8650BX Integrated TBS Upgrade from TBS Insight v3.0 (out of warranty)
H8650BY Integrated TBS Upgrade from TBS Insight version lower than v3.0
H8650NS oneVision
H8650CM
H8650BR Physician Reports (Composer)
H8970SA Practice Mgmt Tools (Business Reports}
H8650CD Sarcopenia
H8650CR ScanCheck (CAD)
H8650SD Small Body Comp ROIs
H8650DC Sports Athletic Package (Child Items H8650LH, H8650CR)
H8650DD DICOM
H8650TD
H8650HL DoD RMF (Includes Mcfee Whitelist License)
H8650NA Teledensitometry
H8650NB HL7
H8650SL
H8650FG Multiuser Database (1-3 users)
H8650AM Multiuser Database (40 users)
H8960BA SOL Server
H8960BB PMT Flash Query
H8960BC PMT Patient Filter
H8960BD
H8960BE HP USB Keyboard Korean
H8960BF HP USB Keyboard Simplified Chinese (China)
H8960BG HP USB Keyboard Portuguese (Brazil)
H8960BH HP USB Keyboard German
HP USB Keyboard Spanish (Latin America)
H8960B) HP USB Keyboard French
HP USB Keyboard Japanese
H8960AA HP USB Keyboard Italian
H8960AB HP USB Keyboard Traditional Chinese (Taiwan)
Power cord, IRAM-2073
Power cord, AS, NZS 3112
Page5 * Printed copies are uncontrolled unless otherwise identified * DOC0108452 (Rev 43)
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EC Declaration of Conformity Lunar iDXA 6GE Healthcare
DOC0108452
H8960AC Power cord, NBR14136
H8960AD Power cord, GB 2099-1/GB 1002
H8960AE Power cord, CEE 7/7
H8960AF Power cord, AFSNIT 107-2-D1
H8960AG Power cord, Japan
H8960AH Power cord, BS 546/SABS 164-1
H8960A! Power cord, Si-32
H8960AK Power cord, CEI 23-16/VII
H8960AL Power cord, BS 1363
H8960AM Power cord, SEV 1011
H8960AN Power cord, 1S1293
Small Room Kit H8699SB Small Room Kit - 230V
Ethernet Cable
H8600SM Small Room Kit - 115V
Ext Opt Kit
Printers* H8600TC iDXA 30 ft Ethernet Cable
USB Hard Drive*
USB DVD-RW* H8698ME iDXA Ext Options Kit
UPS H8600PA Paper Inkjet PTR-500pk
Computer Cart*
H8600PT Printer
Phantoms
*Non-GEHC Printers can be locally sourced using specifications described in DXA with
Scanner Power Cords enCORE User M anual LU43616.
Page 6 H8625AD HD, External, USB
H8910HD Hardware-encrypted USB drive
DVD-RW, External, USB
H8910SB *Non-GEHC USB DVD-RW Drive can be locally sourced using specifications
described in DXA with enCORE User Manual LU43616.
E4502LB UPS, 120V, DXA
E4502LC Cable kit for E4502LB
Computer Cart
H8699SD *Non-GEHC Computer Cart can be locally sourced using specifications
H8602AA described in DXA with enCORE User Manual LU43616.
H8619DA iDXA Encapsulated Phantom
H8619DC Power cord CEE 7/7
H8619DH Power cord AS/NZS 3112
H8619DG Power cord Afsnit 107-2-D1/DK-2-1A
H8619DJ Power cord BS 546/SABS 164-1
H8619DL Power cord CEI 23-16/VII
H8619DN Power cord NEMA 5-15
H8619DR
H8619DZ Power cord BS 1363
H8619DY
H8619DB Power cord Sl 32
Power cord IS 1293
Power cord SEV 1011
Power cord IRAM 2073
* Printed copies are uncontrolled unless otherwise identified * DOC0108452 (Rev 43)
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EC Declaration of Conformity Lunar iDXA
DOC0108452
H8619DD Power cord NBR14136
H8619DF Power cord GB 2099-1 & GB 1002-1
Page 7 * Printed copies are uncontrolled unless otherwise identified * D0C0108452 (Rev 43)
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