Cleared Traditional

K000359 - EBT ULTRAFAST CT SCANNER SYSTEM

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

K000359 is an FDA 510(k) clearance for EBT ULTRAFAST CT SCANNER SYSTEM, manufactured by Imatron, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K000359 · Imatron, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
42d
Days
Class 2
Risk

K000359 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 March 17, 2000 after a review of 42 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

FDA 510(k) Submission Details - K000359

510(k) Number K000359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2000
Decision Date March 17, 2000
Days to Decision 42 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
65d faster than avg
Panel avg: 107d · This submission: 42d
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 714
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K000359.
ULTRASIM CT SYSTEM
K001088 · Philips Medical Systems (Cleveland), Inc. · Jun 2000
PHILIPS CT SECURA MV
K000819 · Philips Medical Systems North America, Inc. · May 2000
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES
K994431 · Shimadzu Medical Systems · Mar 2000
LIGHTSPEED 2.0CT SCANNER SYSTEM
K000300 · Ge Medical Systems, Inc. · Feb 2000
CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
K993645 · Ge Medical Systems, Inc. · Dec 1999
CT PERFUSION OPTION
K993791 · Ge Medical Systems, Inc. · Nov 1999