Cleared Traditional

EBT ULTRAFAST CT SCANNER SYSTEM (K992740) - FDA 510(k) Clearance

Also marketed or referenced as:
ULTRAFAST CT SCANNER SYSTEM C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992740 · Imatron, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
85d
Days
Class 2
Risk

K992740 is an FDA 510(k) clearance for the EBT ULTRAFAST CT SCANNER SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Imatron, Inc. (South San Fransisco, US). The FDA issued a Cleared decision on November 9, 1999 after a review of 85 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 Imatron, Inc. devices

Submission Details

510(k) Number K992740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1999
Decision Date November 09, 1999
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
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 385
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K992740.
SOMATOM EMOTION MS
K003014 · Siemens Medical Solutions USA, Inc. · Oct 2000
LIGTHSPEED 3.0 CT SCANNER SYSTEM
K002978 · GE Medical Systems · Oct 2000
ULTRASIM CT SYSTEM
K001088 · Philips Medical Systems (Cleveland), Inc. · Jun 2000
SOMATOM PROJECT 10-CT SCANNERS
K991764 · Siemens Medical Solutions USA, Inc. · Aug 1999
CALCIUM SCORING
K990426 · Siemens Medical Solutions USA, Inc. · May 1999
FACTS
K982010 · Philips Medical Systems (Cleveland), Inc. · Nov 1998