Cleared Traditional

K864046 - C-IOO MOBILE CINE CT UNIT

K864046 is an FDA 510(k) clearance for C-IOO MOBILE CINE CT UNIT, 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 25-day FDA review.

K864046 · Imatron, Inc. · Radiology device
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Nov 1986
Decision
25d
Days
Class 2
Risk

K864046 is an FDA 510(k) clearance for the C-IOO MOBILE CINE CT UNIT. 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 10, 1986 after a review of 25 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.

FDA 510(k) Submission Details - K864046

510(k) Number K864046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1986
Decision Date November 10, 1986
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
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 825
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K864046.
I.S.G. 3DMV WORKSTATION
K872150 · I.S.G. Technologies, Inc. · Aug 1987
CSI/3D
K870513 · Columbia Scientific, Inc. · May 1987
TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY
K863935 · Toshiba Medical Systems · Dec 1986
CT MAX, CATALOG NO. B7940 HA
K862317 · General Electric Co. · Oct 1986
VISISCAN CT SCANNERS - MODELS V600, V1200 & V2400
K861698 · Visiscan · Oct 1986
SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC
K861708 · General Electric Co. · Aug 1986
K864046 · C-IOO MOBILE CINE CT UNIT
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