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510(k) K233336

21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) by Acula Technology Corp. — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2024
Date Received
September 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Diagnostic Radiology
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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

Other clearances by Acula Technology Corp.

  • K241499 — 21.3” 5MP Color LCD Display UMD5-21B01 (June 13, 2024)

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