SMART PCFD

GUDID 06429810209054

Disior Oy

CAD/CAM software
Primary Device ID06429810209054
NIH Device Record Key37c85cc7-67ad-4e0a-87b2-f0bab081e628
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMART PCFD
Version Model Number1
Company DUNS368480395
Company NameDisior Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106429810209054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-04
Device Publish Date2026-01-27

Devices Manufactured by Disior Oy

06429810209054 - SMART PCFD2026-02-04
06429810209054 - SMART PCFD2026-02-04
06429810209030 - SMART Bun-Yo-Matic™ CT2024-07-22
06429810209047 - SMART Bun-Yo-Matic™ Xray2024-07-22
06429810209221 - Bonelogic2024-01-23
06429810209023 - Bonelogic2021-03-08

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