FDA.reportPublic FDA data

NovaGuide™ 2 Intelligent Ultrasound System

Primary DI
00850681007399
Brand
NovaGuide™ 2 Intelligent Ultrasound System
Company
Novasignal Corp.
Model
05-00030
Catalog number
NSC-NVGSYS2
Published
2022-08-19
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213279000NovaGuide 2 Intelligent UltrasoundNovasignal Corporation2022-03-02IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850681007399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850681007399008506810073998506810073990850681007399

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system, line-poweredA mains electricity (AC-powered) device assembly consisting of a desktop unit, a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis), ankle pressure index, and/or blood flow wave form recording.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078766464
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850681007405NovaGuide™ 2 Traditional Ultrasound SystemNSC-TCDNG2NSC-TCDNG22022-08-19
00850681007443NovaGuide™ Intelligent Ultrasound System05-00019NA-RBTSYS12022-08-19
00850681007221Lucid Transcranial Doppler Ultrasound System (Lucid TCD)NA-LUCM1NA-LUCM12020-08-31
00850681007009Lucid Transcranial Doppler SystemM1NA – LUCM12017-05-10
008506810070162-MHz Transducer, Handheld40-00008NA – PRB12017-05-25
008506810070232-MHz Headset/Monitoring Transducer40-00009NA - PRB22017-05-25
00850681007030Temporal Monitoring Headset40-00010NA – MOUNT12017-05-25
00850681007047Remote Control Accessory10-00002NA-ACC22018-03-20
008506810071532Mhz Monitoring Transducer - 8 footNA-PRB3NA-PRB32018-10-17
00850681007160Temporal Monitoring HeadframeNA-MOUNT2NA-MOUNT22018-10-17
00850681007177Monitoring Headframe Foam Procedural SetNA-DSP3NA-DSP32018-10-17
00850681007283NovaKit™ 2 Exam Pack25-00004NSC-NVK2022-08-19
00850681007351NovaKit™ 2 Exam Pack25-00004NSC-NVK2022-08-19
00850681007184NovaBot Automated HeadsetNA-RBT1NA-RBT12020-08-31
10850681007174Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-PackNA-DSP3PKNA-DSP3PK2020-06-05
00850681007115NeuralBot Procedural Set (Single Use)1.xNA-DSP22018-07-26
00850681007122NeuralBot1.xNA-RBT12018-07-09
00850681007191NovaKit Exam Pack (NovaKit)NA-DSP2NA-DSP22020-08-31
10850681007198NovaKit Exam Pack (NovaKit)NA-DSP2NA-DSP22020-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06903053124348Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124355Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124379Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124430Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124461Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124492Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124546Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124560Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124591Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124607Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124614Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124683Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124706Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124720Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124775Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124829Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
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00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYN2026-06-01
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00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYN2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYN2026-06-01
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04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYN2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYN2026-05-29
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYN2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07