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Calibration Software For Radiology Displays

FDA product code SHN · 1 cleared devices

Class 1 Radiology
Regulation
21 CFR 892.1940
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-04-01 – 2026-04-01

The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology.

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