Puck U & Ud Cutfilm Changers

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K842911 ↗

FDA Product Code

KPX

Device Class

Class II

Regulation

21 CFR Part 892.1860

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Lead Modification

  Class III

  FDA 510(k) K770135 Active Cleared 7 Feb 1977

• Pulse Generator Model 629

  Class III

  FDA 510(k) K790670 Active Cleared 27 Jun 1979

• Puck 90M

  Class II

  FDA 510(k) K903576 Active Cleared 4 Sep 1990

• Sep Programmer for Puck U & Ud Filmchang

  Class II

  FDA 510(k) K842903 Active Cleared 21 Aug 1984

• Pulse Generator Model 637

  Class III

  FDA 510(k) K790792 Active Cleared 12 Oct 1979

• Sep Programmer Sep-M/Single-Plane &

  Class II

  FDA 510(k) K840389 Active Cleared 21 Feb 1984

See all devices from Elema-Schonander, Inc. →

• What is the Puck U & Ud Cutfilm Changer used for?

  The Puck U & Ud Cutfilm Changers are Class II medical devices designed specifically for changing radiographic film/cassettes in medical imaging settings within radiology departments.

• What is the regulatory status of the Puck U & Ud Cutfilm Changer?

  The device received FDA 510(k) clearance on August 21, 1984, with K number K842911. It is classified under product code KPX and regulation number 892.1860 as substantially equivalent to predicate devices.

• Is the Puck U & Ud Cutfilm Changer sterile or single-use?

  The device data does not provide information regarding sterility status or whether the device is designed for single-use or reuse. This information would need to be obtained directly from the manufacturer.

• What sizes or models are available for the Puck U & Ud Cutfilm Changer?

  The device data does not specify available sizes or models beyond the Puck U & Ud designation. For detailed specifications on available configurations, consultation with the manufacturer would be necessary.