Cleared Traditional

K040704 - MODIFICATION TO HENSCHKE HDR CERVIX APP...

K040704 is the FDA 510(k) clearance for MODIFICATION TO HENSCHKE HDR CERVIX APP... by Mick Radio-Nuclear Instruments, Inc.. It is a Class 2 Radiology device (product code JAQ) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K040704 · Mick Radio-Nuclear Instruments, Inc. · Radiology device
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Jun 2004
Decision
92d
Days
Class 2
Risk

K040704 is an FDA 510(k) clearance for the MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX AP.... Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Mick Radio-Nuclear Instruments, Inc. (Mt. Vernon, US). The FDA issued a Cleared decision on June 18, 2004 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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 Mick Radio-Nuclear Instruments, Inc. devices

Submission Details

510(k) Number K040704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2004
Decision Date June 18, 2004
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAQ System, Applicator, Radionuclide, Remote-controlled

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