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Beacon PA27T

by Shenzhen Beacon Display Technology Co., Ltd.

Beacon PA27T is a Class II device made by Shenzhen Beacon Display Technology Co., Ltd., cleared under FDA 510(k) K233119 on 28 Dec 2024 and listed in FDA GUDID since 18 Mar 2025 (UDI-DI 06970027821077), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K233119

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06970027821077 UDI-DI Date18 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233119 Date28 Dec 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233119 decided 28 Dec 2024 Active
  • FDA GUDID UDI-DI 06970027821077 listed 18 Mar 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K233119
  2. Listed FDA GUDID 06970027821077

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Beacon
Generic name
Pathology information system
Model / reference
PA27T
Primary DI / UDI-DI
06970027821077
510(k) Number
FDA product code
PZZ
GMDN term
Pathology information system
Device class
Class II
Regulation number
864.3700
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Pathology information system

Cleared under the same submission (K233119)

Other devices from Shenzhen Beacon Display Technology Co., Ltd.

  • Beacon C22S+

    Class II

  • Beacon C61W+

    Class II

  • Beacon MB5MP

    Class II

  • Beacon C516S

    Class II

See all devices from Shenzhen Beacon Display Technology Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)