Cleared Traditional

K780155 - DUAL CHANNEL PULSE HEIGHT ANALYZER

K780155 is an FDA 510(k) clearance for DUAL CHANNEL PULSE HEIGHT ANALYZER, manufactured by Iso Graphics, Inc.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K780155 · Iso Graphics, Inc. · Radiology device
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Mar 1978
Decision
31d
Days
Class 1
Risk

K780155 is an FDA 510(k) clearance for the DUAL CHANNEL PULSE HEIGHT ANALYZER. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Iso Graphics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1978 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Iso Graphics, Inc. devices

FDA 510(k) Submission Details - K780155

510(k) Number K780155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1978
Decision Date March 02, 1978
Days to Decision 31 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 107d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

IYX Device Classification - Class 1, General Controls

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 90
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K780155.
MAXI-CAMERA 535
K781673 · General Electric Co. · Oct 1978
GAMMA CAMERA
K780855 · G.D. Searle and Co. · Jun 1978
DATA CAMERA
K780491 · General Electric Co. · Apr 1978
GAMMA CAMERAS -GXA-301 & GCA-402
K771599 · Toshiba Medical Systems · Sep 1977
UNIVUE I
K770954 · Union Carbide Corp. · Jul 1977
PORTA CAMERA IIC
K770753 · General Electric Co. · May 1977