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Display, Diagnostic Radiology

FDA product code PGY · 106 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.2050
Review panel
RA
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2016-01-12 – 2026-09-01

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

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