Cleared Traditional

K963730 - PROTEC (1024)

K963730 is an FDA 510(k) clearance for PROTEC (1024), manufactured by Proportional Technologies, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K963730 · Proportional Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
147d
Days
Class 2
Risk

K963730 is an FDA 510(k) clearance for the PROTEC (1024). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Proportional Technologies, Inc. (Houston, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Proportional Technologies, Inc. devices

FDA 510(k) Submission Details - K963730

510(k) Number K963730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date February 10, 1997
Days to Decision 147 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
40d slower than avg
Panel avg: 107d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 356
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K963730.
ISOCAM II (DUAL HEAD GAMMA CAMERA)
K964834 · Park Medical Systems, Inc. · Feb 1997
UHE COLLIMATOR (210591)
K963406 · Philips Medical Systems (Cleveland), Inc. · Feb 1997
PRISM XPVT SYSTEM (210823)
K964712 · Philips Medical Systems (Cleveland), Inc. · Feb 1997
VOLMETRIC COINCIDENCE DETECTION SYSTEM
K962100 · Elscint, Inc. · Jan 1997
GENIE PROCESSING AND REVIEW WORKSTATION
K964012 · GE Medical Systems · Jan 1997
SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
K960948 · Toshiba Medical Systems · Dec 1996