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510(k) K241499

21.3” 5MP Color LCD Display UMD5-21B01 by Acula Technology Corp. — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2024
Date Received
May 28, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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.

  • K233336 — 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) (May 21, 2024)

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