Cleared Traditional

K970647 - OUR ROTATING GAMMA SYSTEM

K970647 is an FDA 510(k) clearance for OUR ROTATING GAMMA SYSTEM, manufactured by Our Scientific Intl., Inc.. The device is a Class 2 Radiology device with product code IWB cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K970647 · Our Scientific Intl., Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
89d
Days
Class 2
Risk

K970647 is an FDA 510(k) clearance for the OUR ROTATING GAMMA SYSTEM. Classified as System, Radiation Therapy, Radionuclide (product code IWB), Class II - Special Controls.

Submitted by Our Scientific Intl., Inc. (Great Neck,, US). The FDA issued a Cleared decision on May 20, 1997 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5750 - 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.

FDA 510(k) Submission Details - K970647

510(k) Number K970647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1997
Decision Date May 20, 1997
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IWB Device Classification - Class 2, Special Controls

Product Code IWB System, Radiation Therapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5750
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 - IWB System, Radiation Therapy, Radionuclide

All 41
Devices cleared under the same product code (IWB) and FDA review panel - the closest regulatory comparables to K970647.
THERATRON ELITE
K983917 · Theratronics, Inc. · Dec 1998
LEKSELL GAMMAPLAN
K973441 · Patterson Consulting Group, Inc. · Apr 1998
THERATRON 780E
K964606 · Theratronics, Inc. · Jun 1997
THE COBALT SCALPEL
K960892 · Nova Therapeutic System · Jun 1996
LEKSELL GAMMA UNIT MODEL 23004,TYPE B.
K924849 · Elekta Radiosurgery, Inc. · Nov 1995
DPD-510 THERAPEUTIC RADIATION DOSIMETER
K925133 · Scanditronix, Inc. · Jan 1993
K970647 · OUR ROTATING GAMMA SYSTEM
Download PDF FDA Summary Our Scientific Intl.,…