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REMEX Xcam6

by REMEDI Inc.

510(k) K250597

REMEX Xcam6 is a medical device (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by REMEDI Inc., cleared under FDA 510(k) K250597 on 31 Jul 2025, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250597 Date31 Jul 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IZL
FDA applicant
Remedi, Inc.
Device class
Class II
Regulation
21 CFR Part 892.1720
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K250597

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K250597
UDI-DISize and differences
REMEX Xcam6
REMEDI CO., LTD.
REMEX Xcam608800060100229 —On the market

Similar devices

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

Other devices from REMEDI Inc.