Cleared Traditional

K945512 - HRSW OPTION FOR CT TWIN FLASH

K945512 is the FDA 510(k) clearance for HRSW OPTION FOR CT TWIN FLASH by Elscint, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K945512 · Elscint, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
125d
Days
Class 2
Risk

K945512 is an FDA 510(k) clearance for the HRSW OPTION FOR CT TWIN FLASH. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on March 14, 1995 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 892.1750 - 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

Submission Details

510(k) Number K945512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1994
Decision Date March 14, 1995
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.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 608
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K945512.
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC
K955254 · Shimadzu Medical Systems · Jan 1996
PHILIPS TOMOSCAN SR 8000
K954255 · Philips Medical Systems North America, Inc. · Oct 1995
PQ5000 CT SYSTEM
K943623 · Philips Medical Systems (Cleveland), Inc. · Apr 1995
CT PROSPEED FAMILY
K944013 · GE Medical Systems · Feb 1995
ANATOM 2000
K944131 · Analogic Corp. · Jan 1995
MEDRAD COUNTERPOISE SYSTEM
K944983 · Medrad, Inc. · Nov 1994