FDA.reportPublic FDA data

VisAR

Primary DI
B109VISAR2880
Brand
VisAR
Company
Novarad Corporation
Model
VisAR 2.88
Device description
VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.
Published
2025-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220146000VisARNovarad Corporation2022-05-27OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B109VISAR2880PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical planning/navigation-enhancement systemA mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.

Contacts#

Phone, Email table
PhoneEmail
18776682723info@novarad.net

Regulatory Flags#

DUNS number
071991843
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B109NOVAPACS81050NovaPACSNovaPACS 8.10.52024-02-09
B109NOVAPACS9160NovaPACSNovaPACS 9.1.62026-05-21
B109NOVAPACS9150NovaPACSNovaPACS 9.1.52025-12-17
B109NOVAPACS9140NovaPACSNovaPACS 9.1.42025-08-20
B109NOVAPACS9130NovaPACSNovaPACS 9.1.32025-05-26
B109NOVAPACS81070NovaPACSNovaPACS 8.10.72024-03-11
B109NOVAPACS8780NovaPACSNovaPACS 8.7.82019-08-16
B109OPENSIGHT187060OpenSightOpenSight 1.87062019-08-16
B109NOVAPACS81030NovaPACSNovaPACS 8.10.32023-06-30
B109NOVAPACS8930NovaPACSNovaPACS 8.9.32022-09-23
B109NOVAPACS8920NovaPACSNovaPACS 8.9.22022-07-11
B109NOVAPACS8910NovaPACSNovaPACS 8.9.12022-04-18
B109NOVAPACS8850NovaPACSNovaPACS 8.8.52022-01-17
B109OPENSIGHT188040OpenSightOpenSight 1.88042021-07-09
B109NOVAPACS8840NovaPACSNovaPACS 8.8.42021-05-03
B109NOVAPACS8830NovaPACSNovaPACS 8.8.32021-01-25
B109NOVAPACS87110NovaPACSNovaPACS 8.7.112020-02-10
B109NOVAPACS8770NovaPACSNovaPACS 8.7.72019-07-12
B109OPENSIGHT180760OpenSightOpenSight 1.80762019-07-12
B109NOVAPACS8760NovaPACSNovaPACS 8.7.62019-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810076335322MomentumUlrich Medical Usa, Inc.OLO2026-09-25
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00810131884062TiLink-L Rescue DilatorSurgentec, LLCOLO2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00860003424834OrthoGrid Hip AIOrthogrid Systems, Inc.LLZ2022-05-19
07649990819006OsiriX MDPixmeo SàrlLLZ2022-02-19
00860003424827OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2021-08-27
00860003424803OrthoGrid HipOrthogrid Systems, Inc.LLZ2021-03-05
00860003424810OrthoGrid Hip PreservationOrthogrid Systems, Inc.LLZ2021-03-05
07613327460667Navigation EnabledStryker CorporationOLO2019-10-16
07613327460674Navigation EnabledStryker CorporationOLO2019-10-16
07613327460681Navigation EnabledStryker CorporationOLO2019-10-16
07613327460698Navigation EnabledStryker CorporationOLO2019-10-16
07613327460704Navigation EnabledStryker CorporationOLO2019-10-16
07613327460711Navigation EnabledStryker CorporationOLO2019-10-16
07613327460728Navigation EnabledStryker CorporationOLO2019-10-16
07613327460735Navigation EnabledStryker CorporationOLO2019-10-16
07613327460742Navigation EnabledStryker CorporationOLO2019-10-16
07613327460759Navigation EnabledStryker CorporationOLO2019-10-16
07613327460766Navigation EnabledStryker CorporationOLO2019-10-16
07613327460773Navigation EnabledStryker CorporationOLO2019-10-16
07613327460780Navigation EnabledStryker CorporationOLO2019-10-16
07613327460797Navigation EnabledStryker CorporationOLO2019-10-16