Cleared Traditional

IDI 200 GAMMA COUNTER (K780790) - FDA 510(k) Clearance

Class I Radiology device.

K780790 · Iso-Data, Inc. · Radiology device
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Jun 1978
Decision
38d
Days
Class 1
Risk

K780790 is an FDA 510(k) clearance for the IDI 200 GAMMA COUNTER. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Iso-Data, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1978 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 862.2320 - 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-Data, Inc. devices

Submission Details

510(k) Number K780790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1978
Decision Date June 22, 1978
Days to Decision 38 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 107d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJJ Counter (beta, Gamma) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2320
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 - JJJ Counter (beta, Gamma) For Clinical Use

All 13
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K780790.
LIQUID SCINTILLATION SPECTROPHOTOMETER
K810345 · Beckman Instruments, Inc. · Feb 1981
PACE-4-AUTOMATIC RIA GAMMA-COUTER
K802578 · Philips Medical Systems (Cleveland), Inc. · Dec 1980
NUCLEAR SAMPLE READER
K790905 · Abbott Laboratories · Jun 1979
PRINTER
K772099 · Miles Laboratories, Inc. · Jan 1978
LIQ. SCINTILLATION SPECTROPHOTOMETEO
K771369 · Beckman Instruments, Inc. · Sep 1977
AUTO-LOGIC II SYSTEM
K771129 · Abbott Laboratories · Aug 1977