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Novarad Corporation

USA · Provo

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 7 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 6Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIb 2Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States7 registration records, 7 510(k), 0 PMA

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: NOVARAD CORP. · NOVARAD CORPORATION

FDA 510(k) clearances by year

22006 · K063153

12014 · K132853

12016 · K160371

12017 · K171754

12018 · K172418

12022 · K220146

FDA listed device types

Orthopedic Stereotaxic Instrument 1System, Image Processing, Radiological 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Medical Device Data System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220146	VisAR	2022-05-27
US	K172418	OpenSight	2018-09-21
US	K171754	NovaPACS	2017-07-28
BR	80770610006	Novarad VisAR System	Class II
BR	80770610005	Surgical Navigation Kit General	Class I
BR	80770610007	Surgical Navigation Kit Specialized	Class I

Novarad Corporation

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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