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BI Image-X Evolution

by Radiotecnología Industrial, S.A. de C.V. 2 variants

BI Image-X Evolution is a Class II device made by Radiotecnología Industrial, S.A. de C.V., cleared under FDA 510(k) K160458 on 20 Jun 2016 and listed in FDA GUDID since 12 Sep 2017 (UDI-DI D881RXEPWEXP0), 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) K160458

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 NumberD881RXEPWEXP0 UDI-DI Date12 Sep 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 D881RXEPWEXP0 listed 12 Sep 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160458
  2. Listed FDA GUDID D881RXEPWEXP0

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  • Withdrawn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
Generic name
Mobile extraoral dental x-ray system, analogue
Model / reference
Evolution
Primary DI / UDI-DI
D881RXEPWEXP0
510(k) Number
FDA product code
EHD
GMDN term
Mobile extraoral dental x-ray system, analogue
Device class
Class II
Regulation number
872.1800
GUDID distribution status
In Commercial Distribution
Size
Angle — 140 degree
Length — 1.6 Meter
Height — 1.8 Meter

Related devices

Category: Mobile extraoral dental x-ray system, analogue

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 Radiotecnología Industrial, S.A. de C.V.

Properties

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