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
B109NOVAPACS9160NovaPACSNovaPACS 9.1.62026-05-21
B109NOVAPACS9150NovaPACSNovaPACS 9.1.52025-12-17
B109VISAR30670VisARVisAR 3.0.672025-12-11
B109NOVAPACS9140NovaPACSNovaPACS 9.1.42025-08-20
B109NOVAPACS9130NovaPACSNovaPACS 9.1.32025-05-26
B109VISAR2730VisARVisAR 2.732024-12-16
B109NOVAPACS81070NovaPACSNovaPACS 8.10.72024-03-11
B109VISAR2150VisARVisAR 2.1.52024-02-12
B109NOVAPACS81050NovaPACSNovaPACS 8.10.52024-02-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
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00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08