Atlas FDA

8MP Color LCD Displays C811W, C811WT, PA27 and PA27T

FDA 510(k) clearance K233119 · decided 2024-12-28

Clearance details

K-number
K233119
Device name
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
Applicant
Shenzhen Beacon Display Technology Co., Ltd.
Decision
Substantially Equivalent
Date received
2023-09-27
Decision date
2024-12-28
Days to decision
458 days
Clearance type
Traditional
Product code
PZZ
Device class
2
Regulation number
864.3700
Medical specialty
Pathology
Advisory committee
Pathology
Location
Shenzhen, CN
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
RadiForce MX317W-PA (K242545)Eizo Corporation2025-05-23
MMPC-4127F1 (K172922)Barco N.V.2017-12-21

Recalls involving this device

No recalls on record reference this clearance.