510(k) K241684

Device
Overjet Charting Assist
Applicant
Overjet, Inc.
510(k) number
K241684
Product code
QIH
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-27
Date received
2024-06-11
Regulation
892.2050
Classification name
Automated Radiological Image Processing Software
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Deepthi Paknikar
Address
50 Milk St. 16th Floor Boston MA US 02109 02109

FDA Registration Numbers

Source Documents

510(k) summary PDF

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