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Xcam

by Hdx Will Corp.

Xcam is a Class II device made by Hdx Will Corp., cleared under FDA 510(k) K192700 on 27 Dec 2019 and listed in FDA GUDID since 28 Apr 2021 (UDI-DI 08800005200175), active as of 31 May 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 31 May 2026

Documents

510(k) K192700

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 31 May 2026.

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800005200175 UDI-DI Date28 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192700 Date27 Dec 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192700 decided 27 Dec 2019 Active
  • FDA GUDID UDI-DI 08800005200175 listed 28 Apr 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192700
  2. Listed FDA GUDID 08800005200175

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Hand-held intraoral dental x-ray system, digital
Model / reference
Xcam
Primary DI / UDI-DI
08800005200175
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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Properties

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