Cleared Traditional

K780790 - IDI 200 GAMMA COUNTER

K780790 is an FDA 510(k) clearance for IDI 200 GAMMA COUNTER, manufactured by Iso-Data, Inc.. The device is a Class 1 Radiology device with product code JJJ cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K780790 · Iso-Data, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K780790

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.

JJJ Device Classification - Class 1, General Controls

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 33
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K780790.
HYDRAGAMMA 16
K800601 · Innotron of Oregon, Inc. · Apr 1980
NML 5000 AUTO. GAMMA SCINT. COUNTER
K800388 · Nuclear Medical Laboratories, Inc. · Mar 1980
NUCLEAR SAMPLE READER
K790905 · Abbott Laboratories · Jun 1979
SCINTILLATION, LIQUID, RACKBETA
K780341 · Lkb Instruments, Inc. · May 1978
GAMMA COUNTER
K780344 · Lkb Instruments, Inc. · Apr 1978
COUNTER, RADIOASSAY, AUTO., MICROMEDIC
K780383 · Micromedic Systems · Mar 1978