HomeAustraliaPrecision AI Pty, Ltd.

Precision AI Pty, Ltd.

Australia · Brisbane Queensland
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 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
5listed device types
Class I 0Class II 5Class III 0
plus 11 registration records and 10 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 2
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 States11 registration records, 10 510(k), 0 PMA, 81 excluded
Brazil0 confirmed, 14 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 9 excluded
Manufacturer names merged into this page: Harrison-AI Medical Pty Ltd · PRECISION AI PTY LTD

Company information

Country
Australia
City
Brisbane Queensland

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.

Business registration

Legal name
PRECISION AI PTY LTD
ABN
41634741012
Registration status
Active
Legal form
Australian Private Company
Registered address
QLD, 4006

Business registration data from Australian Business Register, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

62023 · K231767
12024 · K233992
12025 · K243955
22026 · K253818

FDA listed device types

Radiological Computer-Assisted Triage And Notification Software 1Shoulder Arthroplasty Implantation System 1Radiological Computer-Assisted Prioritization Software For Lesions 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1Shoulder Prosthesis, Reverse Configuration 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253818Annalise Enterprise2026-03-03
USK251558Precision AI Surgical Planning System (PAI-SPS)2026-01-12
USK243955Precision AI Surgical Planning System (PAI-SPS)2025-01-21

Similar companies

ALLICO PACKAGING PTY LTD
Australia · markets 0
Amos Scientific PTY. LTD
Australia · markets 2
Austofix Pty. Ltd.
Australia · markets 0
Axxin Pty Ltd
Australia · markets 1
Care Essentials Pty Ltd
Australia · markets 10
CMS SciDoc Pty Ltd
Australia · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →