Cleared Traditional

K930283 - THYRUS

K930283 is an FDA 510(k) clearance for THYRUS, manufactured by Adac Laboratories. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K930283 · Adac Laboratories · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
151d
Days
Class 1
Risk

K930283 is an FDA 510(k) clearance for the THYRUS. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Adac Laboratories (Milpitas, US). The FDA issued a Cleared decision on June 21, 1993 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Adac Laboratories devices

FDA 510(k) Submission Details - K930283

510(k) Number K930283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1993
Decision Date June 21, 1993
Days to Decision 151 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 107d · This submission: 151d
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 81
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K930283.
R &D BATTERIES, INC. PART # 5015, 5192, 5482
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FAN BEAM COLLIMATOR
K933256 · Siemens Gammasonics, Inc. · Oct 1993
QUANTEM (TM)
K932957 · GE Medical Systems · Aug 1993
UNIX-LINK
K926550 · General Electric Co. · Mar 1993
NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES
K926083 · Biodan Medical Systems, Ltd. · Feb 1993
NEW DETECTOR FOR TRANSCAM/POLARIS S315
K924639 · Adac Laboratories · Jan 1993