Siam 80-INSTANTANEOUS Sonograph W/Stor

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

510(k) Number

K802704 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Ibis II

  Class II

  FDA 510(k) K812963 Active Cleared 24 Nov 1981

• Comptar III

  Class I

  FDA 510(k) K813051 Active Cleared 24 Nov 1981

• Process 100 St

  Class I

  FDA 510(k) K833846 Active Cleared 16 Dec 1983

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  FDA 510(k) K837336 Active Cleared 29 Apr 1983

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  FDA 510(k) K833223 Active Cleared 9 May 1984

• Maximax - 4

  Class II

  FDA 510(k) K841649 Active Cleared 5 Jun 1984

See all devices from Cgr Medical Corp. →

• What is the Siam 80-Instantaneous Sonograph used for?

  The Siam 80-Instantaneous Sonograph is intended for use in radiology to provide immediate sonographic imaging capabilities, as indicated by the term 'instantaneous' in its product name and its classification as a radiology device under advisory committee RA.

• How was the Siam 80-Instantaneous Sonograph cleared for market?

  The device was cleared by the FDA through a traditional 510(k) submission (K802704) in December 1980, determined to be substantially equivalent to a predicate device, as shown by the decision code SESE and clearance type Traditional.

• What regulatory identifiers apply to the Siam 80-Instantaneous Sonograph?

  The device carries the product code IYO, was submitted under k-number K802704 by applicant Cgr Medical Corp., and is classified under advisory committee RA for radiology, with no additional identifiers such as sterility or single-use status provided in the source data.