Cleared Traditional

K914807 - APEX HELIX - A

K914807 is an FDA 510(k) clearance for APEX HELIX - A, manufactured by Elscint, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K914807 · Elscint, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
125d
Days
Class 2
Risk

K914807 is an FDA 510(k) clearance for the APEX HELIX - A. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on February 27, 1992 after a review of 125 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 Elscint, Inc. devices

FDA 510(k) Submission Details - K914807

510(k) Number K914807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1991
Decision Date February 27, 1992
Days to Decision 125 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 slower than avg
Panel avg: 107d · This submission: 125d
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 386
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K914807.
GE 4096 PLUS & GE 2048
K914267 · GE Medical Systems · Jul 1992
ECAT EXACT HR MODEL 961
K920624 · Cti Pet Systems, Inc. · Apr 1992
OPTIMA NUCLEAR TOMOGRAPHY STYSTEM
K915470 · General Electric Co. · Apr 1992
ECAT SCANNER (MODEL 921)
K913637 · Cti Pet Systems, Inc. · Nov 1991
CEQUAL(TM)
K914527 · General Electric Co. · Nov 1991
CARDIOFOCAL COLLIMATOR
K914179 · Siemens Gammasonics, Inc. · Oct 1991