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Terarecon, Inc.

USA · Durham

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel — 7 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

3listed device types

Class I 1Class II 2Class III 0

plus 13 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

1active device licences

Class II 1

13 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States13 registration records, 14 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: Terarecon, Inc. · TERARECON, INC.

FDA 510(k) clearances by year

11998

12000

22001

12006

22013

12018

12019

12020

12022

12024

22025

FDA listed device types

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1System, Digital Image Communications, Radiological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250288	TeraRecon Cardiovascular.Calcification.CT	2025-10-23
US	K243158	TeraRecon Aorta.CT (1.1.0)	2025-01-23
US	K241312	TeraRecon Cardiac.Chambers.MR (1.0.0)	2024-11-05
BR	80102513487	Algoritmo TeraRecon Neuro	Class II
BR	80102510440	SISTEMA INTUITION	Class II
CA	78777	AQUARIUS WORKSTATION	Class II

Terarecon, Inc.

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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