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Pie Medical

USA · Indianpolis
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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 0Class II 4Class III 0
plus 10 registration records and 51 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
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
3active device licences
Class II 3
7 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States10 registration records, 51 510(k), 0 PMA, 1 excluded
Brazil3 confirmed, 1 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: PIE MEDICAL IMAGING B.V. · PIE MEDICAL IMAGING BV
Same-named companies — This database also contains companies with near-identical names: Pie Medical Imaging BV. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Indianpolis

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11995
11998
22000
32001
22002
22003
32004
42005
32006
12009
12010
22012
12013
12014
12015
42016
22018
12022
22024
12025

FDA listed device types

System, Image Processing, Radiological 1X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device 1Automated Radiological Image Processing Software 1System, X-Ray, Angiographic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK2503303mensio Workstation2025-11-03
USK232147CAAS Workstation2024-04-09
USK232007CAAS MR Solutions2024-02-01
BR80047300797CAAS WORKSTATIONClass II
BR800473007923MENSIO WORKSTATIONClass II
BR80047300810CAAS WORKSTATIONClass II
CA74515CAAS CARDIOVASCULAR ANGIOGRAPHY ANALYSIS SYSTEMClass II
CA88463CARDIOVASCULAR ANGIOGRAPHIC ANALYSIS SYSTEM (CAAS) A-VALVEClass II
CA884643MENSIO WORKSTATIONClass II

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