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Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

FDA product code POK · 22 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.2060
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-07-03 – 2026-07-02

Assist users in characterizing lesions identified on acquired medical images

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