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Bi Image X-Evolution Wall EL-X20070

by Dpm USA Corp

Bi Image X-Evolution Wall EL-X20070 (PC17B) is a Class II device made by Dpm USA Corp, cleared under FDA 510(k) K160458 on 20 Jun 2016 and listed in FDA GUDID since 8 Nov 2017 (UDI-DI 10850786008014), active as of 23 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 23 Oct 2026

Documents

510(k) K160458

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10850786008014 UDI-DI Date8 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160458 Date20 Jun 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160458 decided 20 Jun 2016 Active
  • FDA GUDID UDI-DI 10850786008014 listed 8 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160458
  2. Listed FDA GUDID 10850786008014

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bi Image X-Evolution Wall
Generic name
Stationary extraoral dental x-ray system, digital
Model / Ref / Catalog
EL-X20070, PC17B
Primary DI / UDI-DI
10850786008014
510(k) Number
FDA product code
EHD
GMDN term
Stationary extraoral dental x-ray system, digital
Device class
Class II
Regulation number
872.1800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stationary extraoral dental x-ray system, digital

Cleared under the same submission (K160458)

Similar devices

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

Other devices from Dpm USA Corp

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)