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Canon Inc. Csx-30

by Canon Inc.

Canon Inc. Csx-30 is a medical device (FDA Class II) made by Canon Inc., cleared under FDA 510(k) K162909 on 27 Jan 2017 and listed in FDA GUDID since 14 Mar 2017 (UDI-DI 04549292075175), 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) K162909

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 Number04549292075175 UDI-DI Date14 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162909 Date27 Jan 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162909 decided 27 Jan 2017 Active
  • FDA GUDID UDI-DI 04549292075175 listed 14 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162909
  2. Listed FDA GUDID 04549292075175

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Canon Inc.
Generic name
Stationary general-purpose fluoroscopic x-ray system, digital
Model / reference
CSX-30
Primary DI / UDI-DI
04549292075175
510(k) Number
FDA product code
JAA, MQB
GMDN term
Stationary general-purpose fluoroscopic x-ray system, digital
Device class
Class II
Regulation number
892.1650, 892.1680
GUDID distribution status
In Commercial Distribution

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Properties

  • Serial number
Other properties (14, all answered No)