FDA.reportPublic FDA data

NA

Primary DI
00840682111157
Brand
NA
Company
PARALLEL DESIGN
Model
6S-RS
Published
2016-07-15
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
IYNSystem, imaging, pulsed doppler, ultrasonic
IYOSystem, imaging, pulsed echo, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151028000LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics2015-06-18IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682111157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682111157008406821111578406821111570840682111157

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius60 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
391532137
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682124355NAL2-9-D57452802018-02-23
00840682124768NAL2-9VN-D57548062018-02-23
00840682114462NAIC5-9W-RS2016-07-15
00840682115346NA6S2016-07-15
00840682114455NAE8CS2016-07-15
00840682110976NA12S-D2016-07-15
00840682111263NA6S-D2016-07-15
00840682111416NA12S-RS2016-07-15
00840682136075NAL3-12-RS2018-10-02
00840682111966NAM5Sc-D2016-07-15
00840682112772NALK760-RS2016-07-15
00840682116527NA3Sc-RS2016-07-15
00840682117883NAM5Sc-RS2016-10-06
00840682124232NA10T-D2018-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719873001101Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYO2026-11-04
04719873001101Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2026-11-04
04719873001101Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
04719873001132Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2026-11-04
04719873001132Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
04719873001132Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYO2026-11-04
04719873001156Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYO2026-11-04
04719873001156Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2026-11-04
04719873001156Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
06903053063852Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063869Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063876Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063883Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063890Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053063890Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063890Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
06903053063906Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063913Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063937Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063944Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063944Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053063944Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
06903053063951Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063968Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063975Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063982Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053064002Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
06903053064002Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053064002Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053064019Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31