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Curix Ortho Fast 24X30

by Agfa Corp. 2 variants

Curix Ortho Fast 24X30 (3KOPY) is a Class II device made by Agfa Corp., cleared under FDA 510(k) K023020 on 26 Sep 2002 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05414904033074), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K023020

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 Number05414904033074 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK023020 Date26 Sep 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K023020 decided 26 Sep 2002 Active
  • FDA GUDID UDI-DI 05414904033074 listed 1 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1404-05 FDA Unclassified (pre-2012) initiated 26 Jan 2005

    Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.

Timeline

3 dated events

  1. Cleared FDA 510(k) K023020
  2. Recall initiated FDA recalls Z-1404-05
  3. Listed FDA GUDID 05414904033074

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Curix Ortho Fast
Generic name
X-ray film cassette, manual
Model / Ref / Catalog
CURIX ORTHO FAST 24X30, 3KOPY
Description
CURIX CAS EU+OR FAST 24X30
Primary DI / UDI-DI
05414904033074
510(k) Number
FDA product code
IXA
GMDN term
X-ray film cassette, manual
Device class
Class II
Regulation number
892.1850
GUDID distribution status
In Commercial Distribution
Size
Length — 24 Centimeter
Width — 30 Centimeter

Related devices

Category: X-ray film cassette, manual

Cleared under the same submission (K023020)

and 8 more cleared under K023020

Similar devices

Other devices filed under FDA product code IXA (Cassette, radiographic film).

Other devices from Agfa Corp.

See all devices from Agfa Corp. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)