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XpectVision XVbeam2000

by Shenzhen Xpectvision Technology Co., Ltd.

XpectVision XVbeam2000 is a Class II device made by Shenzhen Xpectvision Technology Co., Ltd., cleared under FDA 510(k) K233914 on 8 Feb 2024 and listed in FDA GUDID since 21 Feb 2024 (UDI-DI 06972259248028), 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) K233914

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 Number06972259248028 UDI-DI Date21 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233914 Date8 Feb 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233914 decided 8 Feb 2024 Active
  • FDA GUDID UDI-DI 06972259248028 listed 21 Feb 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K233914
  2. Listed FDA GUDID 06972259248028

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
XpectVision
Generic name
Hand-held intraoral dental x-ray system, digital
Model / reference
XVbeam2000
Primary DI / UDI-DI
06972259248028
510(k) Number
FDA product code
EHD
GMDN term
Hand-held intraoral dental x-ray system, digital
Device class
Class II
Regulation number
872.1800
GUDID distribution status
In Commercial Distribution

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Other devices filed under Hand-held intraoral dental x-ray system, digital.

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Properties

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