Cleared Traditional

K001550 - EBT ULTRAFAST CT SCANNER SYSTEM

Also marketed or referenced as:
C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS ELECTRON BEAM SCANNER SYSTEM ELECTR

K001550 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 LLZ cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K001550 · Imatron, Inc. · Radiology device
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Dec 2000
Decision
207d
Days
Class 2
Risk

K001550 is an FDA 510(k) clearance for the EBT ULTRAFAST CT SCANNER SYSTEM. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Imatron, Inc. (South San Fransisco, US). The FDA issued a Cleared decision on December 11, 2000 after a review of 207 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate-to-high equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Imatron, Inc. devices

FDA 510(k) Submission Details - K001550

510(k) Number K001550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2000
Decision Date December 11, 2000
Days to Decision 207 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
100d slower than avg
Panel avg: 107d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1737
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K001550.
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K002424 · Toshiba America Medical Systems, In.C · Oct 2000
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K002144 · Advanced Technology Laboratories, Inc. · Sep 2000