Cleared Traditional

K843716 - NUCLEAR 700 MEDICINE MECHANICAL POSIT-

K843716 is an FDA 510(k) clearance for NUCLEAR 700 MEDICINE MECHANICAL POSIT-, manufactured by Technicare Corp.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K843716 · Technicare Corp. · Radiology device
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Dec 1984
Decision
84d
Days
Class 1
Risk

K843716 is an FDA 510(k) clearance for the NUCLEAR 700 MEDICINE MECHANICAL POSIT-. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Technicare Corp. (Cleveland, US). The FDA issued a Cleared decision on December 17, 1984 after a review of 84 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 Technicare Corp. devices

FDA 510(k) Submission Details - K843716

510(k) Number K843716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1984
Decision Date December 17, 1984
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 107d · This submission: 84d
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 64
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K843716.
BASICAM COUNTER BALANCE CAMERA
K850463 · Siemens Gammasonics, Inc. · Apr 1985
ORBITOR II COUNTER BALANCE CAMERA
K850397 · Siemens Gammasonics, Inc. · Mar 1985
TOMOGRAPHIC GANTRY
K844218 · General Electric Co. · Mar 1985
MAXICAMERA 400 AC
K841906 · General Electric Co. · Jul 1984
DIGITAL PROCESSING SYSTEM
K840052 · Adac Laboratories · Mar 1984
CARDIAC CAMERA
K833811 · Siemens Gammasonics, Inc. · Dec 1983