21.3” 5MP Color LCD Display UMD5-21B01

FDA 510(k) K241499 · Acula Technology Corp.

Substantially Equivalent

510(k) numberK241499

Submission

Device name
21.3” 5MP Color LCD Display UMD5-21B01
Applicant
Acula Technology Corp.
Taoyuan, TW
Received
May 28, 2024
Decision date
June 13, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
PGY – Display, Diagnostic Radiology
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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

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More from Eizo Corporation

510(k)DeviceDecision
K23333621.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)PGY · Traditional 05/21/2024SE

Questions and answers

When was 21.3” 5MP Color LCD Display UMD5-21B01 cleared by the FDA?

21.3” 5MP Color LCD Display UMD5-21B01 (K241499) received a 510(k) decision of Substantially Equivalent on June 13, 2024, 16 days after the submission was received.

What is the product code of K241499?

The FDA product code is PGY – Display, Diagnostic Radiology, a Class II (moderate risk) device regulated under 21 CFR 892.2050.