Cleared Traditional

K900170 - MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U

K900170 is an FDA 510(k) clearance for MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U, manufactured by Elscint, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K900170 · Elscint, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
194d
Days
Class 2
Risk

K900170 is an FDA 510(k) clearance for the MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Elscint, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on July 25, 1990 after a review of 194 days - an extended review cycle.

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

FDA 510(k) Submission Details - K900170

510(k) Number K900170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1990
Decision Date July 25, 1990
Days to Decision 194 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 107d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

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 747
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K900170.
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K903763 · General Electric Co. · Nov 1990
CT GUIDE (TM)
K903622 · Radi Medical Systems AB · Oct 1990
XPEED COMPUTED TOMOGRAPHY X-RAY SYSTEM
K902557 · Toshiba America Medical Systems, In.C · Aug 1990
TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE
K900660 · Philips Medical Systems North America, Inc. · Mar 1990
TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM
K896456 · Toshiba America Medical Systems, In.C · Mar 1990
TCT-300S - UPGRADE
K900233 · Toshiba America Medical Systems, In.C · Feb 1990