FDA.report

510(k) K230023

Device
ART-Plan
Applicant
Therapanacea Sas
510(k) number
K230023
Product code
QKB
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-19
Date received
2023-01-04
Regulation
892.2050
Classification name
Radiological Image Processing Software For Radiation Therapy
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Catherine Martineau-Huynh
Address
7 Bis Blvd. Bourdon Paris FR 75004 75004

FDA Registration Numbers

Source Documents

510(k) summary PDF

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