Cleared Traditional

K922117 - C-TRAK BIOPSY SYSTEM

K922117 is an FDA 510(k) clearance for C-TRAK BIOPSY SYSTEM, manufactured by Care Wise Medical Products Corp.. The device is a Class 1 Radiology device with product code IZD cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K922117 · Care Wise Medical Products Corp. · Radiology device
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Oct 1992
Decision
162d
Days
Class 1
Risk

K922117 is an FDA 510(k) clearance for the C-TRAK BIOPSY SYSTEM. Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Care Wise Medical Products Corp. (Morgan Hill, US). The FDA issued a Cleared decision on October 14, 1992 after a review of 162 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1320 - 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 Care Wise Medical Products Corp. devices

FDA 510(k) Submission Details - K922117

510(k) Number K922117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1992
Decision Date October 14, 1992
Days to Decision 162 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 107d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

IZD Device Classification - Class 1, General Controls

Product Code IZD Probe, Uptake, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1320
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 - IZD Probe, Uptake, Nuclear

All 7
Devices cleared under the same product code (IZD) and FDA review panel - the closest regulatory comparables to K922117.
GAMMA GUIDANCE SYSTEM
K961321 · Radiation Monitoring Devices, Inc. · Feb 1997
NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES
K962319 · Neoprobe Corp. · Sep 1996
THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME
K932153 · Biodan Medical Systems, Ltd. · Sep 1993
CARDIAC PROBE
K760595 · G.D. Searle and Co. · Sep 1976