Skip to content

Lux 35 Detector

by Carestream Health

510(k) K203159

Lux 35 Detector is a Class II device made by Carestream Health, cleared under FDA 510(k) K203159 on 2 Dec 2020, 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 · Special NumberK203159 Date2 Dec 2020ClearedStatusActive

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  • Withdrawn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
MQB
Device class
Class II
Regulation
21 CFR Part 892.1680
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

Cited by

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

Similar devices

Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

Other devices from Carestream Health, Inc.

See all devices from Carestream Health, Inc. →