Cleared Traditional

K884668 - EXEL 1002 CT SCANNER

K884668 is the FDA 510(k) clearance for EXEL 1002 CT SCANNER by Elscint, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K884668 · Elscint, Inc. · Radiology device
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Dec 1988
Decision
52d
Days
Class 2
Risk

K884668 is an FDA 510(k) clearance for the EXEL 1002 CT SCANNER. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Elscint, Inc. (Boston, US). The FDA issued a Cleared decision on December 30, 1988 after a review of 52 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elscint, Inc. devices

Submission Details

510(k) Number K884668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1988
Decision Date December 30, 1988
Days to Decision 52 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
55d faster than avg
Panel avg: 107d · This submission: 52d
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 K884668.
EXEL 1800 AND 1800E CT SCANNER
K884670 · Elscint, Inc. · Jan 1989
EXEL 2400 AND 2400 ELITE CT SCANNERS
K884671 · Elscint, Inc. · Jan 1989
EXEL 905 SERIES CT SCANNER
K884667 · Elscint, Inc. · Dec 1988
EXEL 2002 & 2002FS CT SCANNER
K884669 · Elscint, Inc. · Dec 1988
TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM
K881305 · Toshiba Medical Systems · Oct 1988
P-7 COMPUTED TOMOGRAPHY SYSTEM
K882378 · Philips Medical Systems (Cleveland), Inc. · Oct 1988