FDA.reportPublic FDA data

Temporal Monitoring Headframe

Primary DI
00850681007160
Brand
Temporal Monitoring Headframe
Company
Novasignal Corp.
Model
NA-MOUNT2
Catalog number
NA-MOUNT2
Published
2018-10-17
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160442000Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz TransducersNeural Analytics, Inc.2016-10-21IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850681007160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850681007160008506810071608506810071600850681007160

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system probeA hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). This is a reusable device.

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
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
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
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027419LA2-9SDSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290028638CA2-8ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029390EV2-10ASAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029420CV1-8AESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029512LA3-16ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029604L3-22SAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029611LA3-22AISAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029741EA2-11AVESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029789EA2-11ARESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.ITX2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08800289979132cV4 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07