FDA.reportPublic FDA data

NovaKit Exam Pack (NovaKit)

Primary DI
00850681007191
Brand
NovaKit Exam Pack (NovaKit)
Company
Novasignal Corp.
Model
NA-DSP2
Catalog number
NA-DSP2
Device description
The NovaKit contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
OQQDiagnostic Ultrasonic Transducer, Robotic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
OQQDiagnostic Ultrasonic Transducer, RoboticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180455000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180455000NeuralBotNeural Analytics, Inc.2018-05-22IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850681007198PackageGS110In Commercial Distribution
00850681007191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085068100719810850681007198
00850681007191008506810071918506810071910850681007191

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound support kitA collection of non-sterile, non-powered, noninvasive devices intended to support a noninvasive vascular ultrasound system during location and assessment of vascular flow using ultrasound/Doppler/transit time technology. It consists of non-electronic supportive devices such as patient pads/positioners, transducer covers, and skin marking stickers. This is a single-use device.

Regulatory Flags#

DUNS number
078766464
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850681007399NovaGuide™ 2 Intelligent Ultrasound System05-00030NSC-NVGSYS22022-08-19
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
10850681007198NovaKit Exam Pack (NovaKit)NA-DSP2NA-DSP22020-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYN2026-07-10
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYN2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00841517112646L15-4FUJIFILM SONOSITE, INC.IYN2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.IYN2026-06-22
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
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