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DRX-Compass

by Carestream Health, Inc.

510(k) K201373

DRX-Compass is a Class II device made by Carestream Health, Inc., cleared under FDA 510(k) K201373 on 26 Jun 2020, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK201373 Date26 Jun 2020ClearedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1206-2023 FDA Class II initiated 30 Jan 2023

    After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury

Timeline

2 dated events

  1. Cleared FDA 510(k) K201373
  2. Recall initiated FDA recalls Z-1206-2023

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  • Withdrawn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
KPR
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

Devices cleared under K201373

13 devices · 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 K201373
UDI-DISize and differences
8622359
CARESTREAM HEALTH, INC.
8622359 / NONE60889978622351
Prescription: no
On the market
DRX-Compass X-ray System
CARESTREAM HEALTH, INC.
6704878 / DRX-Compass X-ray System60889976704875
Prescription: yes
On the market
DRX-Compass X-ray System
CARESTREAM HEALTH, INC.
6704894 / DRX-Compass X-ray System60889976704899
Prescription: yes
On the market
DRX-COMPASS X-RAY SYSTEM
CARESTREAM HEALTH, INC.
8621617 / DRX-COMPASS X-RAY SYSTEM60889978621613
Prescription: no
On the market
DRX-Compass X-ray System
CARESTREAM HEALTH, INC.
8624181 / DRX-Compass X-ray System60889978624188
Prescription: yes
On the market
DRX-Compass X-ray System
CARESTREAM HEALTH, INC.
8624199 / DRX-Compass X-ray System60889978624195
Prescription: yes
On the market
DRX-Compass X-ray System
CARESTREAM HEALTH, INC.
8624736 / DRX-Compass X-ray System60889978624737
Prescription: yes
On the market
DRX-Compass X-ray System
CARESTREAM HEALTH, INC.
8624744 / DRX-Compass X-ray System60889978624744
Prescription: yes
On the market
DRX-Compass X-ray System
CARESTREAM HEALTH, INC.
8624769 / DRX-Compass X-ray System60889978624768
Prescription: yes
On the market
Value Systems
CARESTREAM HEALTH, INC.
6701528 / Value Systems60889976701522
Prescription: no
On the market
Value Systems
CARESTREAM HEALTH, INC.
6701536 / Value Systems60889976701539
Prescription: yes
On the market
Value Systems
CARESTREAM HEALTH, INC.
8621658 / Value Systems60889978621651
Prescription: no
On the market
Value Systems
CARESTREAM HEALTH, INC.
8621666 / Value Systems60889978621668
Prescription: no
On the market

Similar devices

Other devices filed under FDA product code KPR (System, X-Ray, Stationary).

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