Hicor

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

510(k) Number

K914313 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K911078 Active Cleared 17 Jun 1991

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  Class II

  FDA 510(k) K920319 Active Cleared 20 Oct 1992

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  Class I

  FDA 510(k) K934766 Active Cleared 18 Feb 1994

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  FDA 510(k) K903767 Active Cleared 7 Sep 1990

• Gamma Camera

  Class I

  FDA 510(k) K810974 Active Cleared 13 May 1981

• Siemens Pacs/I-a

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  FDA 510(k) K880690 Active Cleared 31 Oct 1988

See all devices from Siemens Gammasonics, Inc. →

• What is the primary purpose of the Hicor system?

  The Hicor is an angiographic X-ray system engineered for use in the field of radiology. It is specifically designed to facilitate diagnostic imaging procedures through the application of X-ray technology.

• What is the regulatory classification of this device?

  The Hicor is classified as a Class II medical device under regulation 892.1600. It has received FDA 510(k) clearance as a substantially equivalent system.

• Who is the manufacturer of the Hicor system?

  The Hicor system is manufactured by Siemens Gammasonics, Inc., located in Hoffman Estates, Illinois.