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REMEX Xcam6

by Remedi Co., Ltd.

REMEX Xcam6 is a portable basic diagnostic x-ray system (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by Remedi Co., Ltd., cleared under FDA 510(k) K250597 on 31 Jul 2025 and listed in FDA GUDID since 22 Jan 2026 (UDI-DI 08800060100229), 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) K250597

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 Number08800060100229 UDI-DI Date22 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK250597 Date31 Jul 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250597 decided 31 Jul 2025 Active
  • FDA GUDID UDI-DI 08800060100229 listed 22 Jan 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K250597
  2. Listed FDA GUDID 08800060100229

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Portable basic diagnostic x-ray system, digital
Model / reference
REMEX Xcam6
Primary DI / UDI-DI
08800060100229
510(k) Number
FDA product code
IZL
GMDN term
Portable basic diagnostic x-ray system, digital
Device class
Class II
Regulation number
892.1720
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IZL (System, X-Ray, Mobile).

Other devices from Remedi Co., Ltd.

See all devices from Remedi Co., Ltd. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)