Cleared Traditional

K973786 - NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE

K973786 is an FDA 510(k) clearance for NORTHWEST RADIATION THERAPY PRODUCTS, manufactured by Nw Radiation Therapy Products. The device is a Class 1 Radiology device with product code IWJ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K973786 · Nw Radiation Therapy Products · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
88d
Days
Class 1
Risk

K973786 is an FDA 510(k) clearance for the NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Nw Radiation Therapy Products (Seattle,, US). The FDA issued a Cleared decision on January 2, 1998 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5650 - 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 Nw Radiation Therapy Products devices

FDA 510(k) Submission Details - K973786

510(k) Number K973786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1997
Decision Date January 02, 1998
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

IWJ Device Classification - Class 1, General Controls

Product Code IWJ System, Applicator, Radionuclide, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5650
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 - IWJ System, Applicator, Radionuclide, Manual

All 22
Devices cleared under the same product code (IWJ) and FDA review panel - the closest regulatory comparables to K973786.
REGANES RADIONUCLIDE SEED MAGAZINE
K972554 · Avid N.I.T., Inc. · Feb 1998
N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
K973037 · Avid N.I.T., Inc. · Jan 1998
WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET
K974118 · Worldwide Medical Technologies, LLC · Jan 1998
N.I.T., INC. NEEDLE GUIDING TEMPLATE
K973638 · Avid N.I.T., Inc. · Dec 1997
PROSTATE SEEDING NEEDLE
K973184 · Promex, Inc. · Nov 1997
MANAN PROSTATE UNI-LOCK
K963743 · Manan Medical Products, Inc. · Dec 1996