FDA.reportPublic FDA data

NA

Primary DI
00840682105262
Brand
NA
Company
GE PARALLEL DESIGN, INC.
Model
3S-RS
Device description
3S-RS
Published
2016-07-15
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
ITXTransducer, ultrasonic, diagnostic
IYNSystem, imaging, pulsed doppler, ultrasonic
IYOSystem, imaging, pulsed echo, ultrasonic
LLZSystem, image processing, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121063000VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEMGe Medical System Israel , Ltd.2012-08-21IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682105262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682105262008406821052628406821052620840682105262

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

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-40 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
623906971
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278002730NAML4-20VN-DH44901AU2021-11-18
00840682105231NA4C-D2016-07-15
00840682107174NAi12L-RS2016-07-15
00840682113311NA5S2016-07-15
00840682115230NA8L2016-07-15
00840682107051NA10S-RS2016-07-15
00840682107129NA8L-RS2016-07-15
00840682107143NA7S-RS2016-05-31
00840682105248NA4C2016-07-15
00840682113045NAM4S2016-07-15
00840682113205NA7S2016-07-15
00840682113281NA3V2016-07-15
00840682115216NA5CS2016-07-15
00840682115223NA3S2016-07-15
00840682115254NA3.5C2016-07-15
00840682115247NAi12L2016-07-15
00840682112598NA3V-D2016-07-15
00195278002723NAML4-20-DH44901AT2021-11-18
00840682142366NA6Vc-D2020-08-07
00840682108676NAC4-8-D2016-07-15

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Primary DI, Brand, Company table
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00860013868918MICSI-PETMicroStructure Imaging, Inc.LLZ2026-10-14
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00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
00198953083246VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
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00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
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00198953083260VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
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06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.IYO2026-09-30
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08809887550187EdgeFlow UH10EEdgeCare Inc.IYO2026-09-30
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