X-Ray, Portable

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K781276 ↗

FDA Product Code

IZL

Device Class

Class II

Regulation

21 CFR Part 892.1720

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K875270 Active Cleared 19 Jan 1988

• Watchchild Obsterical Patient Data Management System

  Class II

  FDA 510(k) K974248 Active Cleared 7 Oct 1998

• Isolette Incubator

  Class II

  FDA 510(k) K781876 Active Cleared 7 Dec 1978

• Duo-Lite Phototherapy System

  Class II

  FDA 510(k) K971256 Active Cleared 24 Sep 1997

• Monitoring System AS100-AS115 Record

  Class I

  FDA 510(k) K832754 Active Cleared 22 Dec 1983

• Rw Resucitaire Infant Radiant Warmer

  Class II

  FDA 510(k) K940951 Active Cleared 3 May 1995

See all devices from Air-Shields, Inc. →

• What is the intended use of the Portable X-Ray System?

  The Portable X-Ray System is intended for use in radiology, providing a mobile x-ray solution.

• Is the Portable X-Ray System cleared by the FDA?

  Yes, the Portable X-Ray System has been cleared under FDA 510(k) clearance K781276, with a decision date of 1978-08-10.

• What is the product code for the Portable X-Ray System?

  The product code for the Portable X-Ray System is IZL, with a regulation number of 892.1720.