ScanNav Anatomy Peripheral Nerve Block

Primary DI
05060878810021
Brand
ScanNav Anatomy Peripheral Nerve Block
Company
INTELLIGENT ULTRASOUND LIMITED
Model
V1.1
Device description
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD)which assists qualified healthcare professionals to identify anatomy in live ultrasound images.The Anatomy PNB receives scan images in real-time from a compatible general-purposeultrasound machine. It then processes the images using deep learning artificial intelligencealgorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. Theoriginal view from the ultrasound machine is not affected and is always available both on theultrasound machine and the Anatomy PNB.
Published
2023-03-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
QRGUltrasound Guided Nerve Block Assist

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRGUltrasound Guided Nerve Block AssistAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220024000ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited2022-10-18QRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060878810021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060878810021050608788100215060878810021

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
218445981
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060878810052ScanNav Anatomy Peripheral Nerve BlockV2.02023-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060878810052ScanNav Anatomy Peripheral Nerve BlockINTELLIGENT ULTRASOUND LIMITEDQRG2023-11-06