Home›USA›FAXITRON BIOPTICS , LLC

FAXITRON BIOPTICS , LLC

USA · Tucson

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Israel, Russia — 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

5510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

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

2 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States0 registration records, 5 510(k), 0 PMA, 1 excluded

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: FAXITRON BIOPTICS , LLC · FAXITRON BIOPTICS, LLC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K183142	PathVisionXL	2019-03-14
US	K173309	Faxitron VisionCT	2018-05-09
US	K170786	Faxitron Bioptics Speciemen Radiography System	2017-07-18
BR	80204389001	FAXITRON PATHVISION	Class I
BR	80204389002	DIGITAL SPECIMEN RADIOGRAPHY SYSTEM	Class I
BR	80204389003	DIGITAL SPECIMEN RADIOGRAPHY SYSTEM	Class I

FAXITRON BIOPTICS , LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

Similar companies