Cleared Traditional

K142597 - Vienna System

K142597 is an FDA 510(k) clearance for Vienna System, manufactured by Mick Radio-Nuclear Instruments, Inc.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K142597 · Mick Radio-Nuclear Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
157d
Days
Class 2
Risk

K142597 is an FDA 510(k) clearance for the Vienna System. 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 February 19, 2015 after a review of 157 days - an extended review cycle.

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

FDA 510(k) Submission Details - K142597

510(k) Number K142597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2014
Decision Date February 19, 2015
Days to Decision 157 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
50d slower than avg
Panel avg: 107d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAQ Device Classification - Class 2, Special Controls

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

All 160
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K142597.
Kobold Ring and Tandem Applicator Set
K142330 · Kobold, LLC · Apr 2015
PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113
K141624 · Varian Medical Systems, Inc. · Mar 2015
Martinez Prostate Template Set
K142439 · Nucletron B.V. · Mar 2015
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
K141490 · Varian Medical Systems, Inc. · Sep 2014
SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS
K141336 · Varian Medical Systems, Inc. · Aug 2014
LUNERAY
K140803 · Nucletron B.V. · Jun 2014