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Xtg 1

by DigiMed Co., Ltd.

Xtg 1 is a hand-held intraoral dental x-ray system (FDA Class II; FDA product code EHD, Unit, X-Ray, Extraoral With Timer) made by DigiMed Co., Ltd., cleared under FDA 510(k) K181891 on 10 Aug 2018 and listed in FDA GUDID since 1 Jun 2026 (UDI-DI 08800021800168), active as of 12 Nov 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 12 Nov 2026

Documents

510(k) K181891

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800021800168 UDI-DI Date1 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181891 Date10 Aug 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181891 decided 10 Aug 2018 Active
  • FDA GUDID UDI-DI 08800021800168 listed 1 Jun 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181891
  2. Listed FDA GUDID 08800021800168

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Xtg
Generic name
Hand-held intraoral dental x-ray system, digital
Model / Ref / Catalog
1
Primary DI / UDI-DI
08800021800168
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

Related devices

Cleared under the same submission (K181891)

Similar devices

Other devices filed under FDA product code EHD (Unit, X-Ray, Extraoral With Timer).

Other devices from DigiMed Co., Ltd.

  • Xtg V 1

    Class II

  • XTG PRO 70 HYBRID Pro

    Class II

  • Diox-602 1 Open recall

    Class II

  • Biox 1

    Class II

See all devices from DigiMed Co., Ltd. →

Properties

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