Cleared Traditional

K861698 - VISISCAN CT SCANNERS - MODELS V600, V1200 & V2400

K861698 is an FDA 510(k) clearance for VISISCAN CT SCANNERS - MODELS V600, manufactured by Visiscan. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K861698 · Visiscan · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1986
Decision
151d
Days
Class 2
Risk

K861698 is an FDA 510(k) clearance for the VISISCAN CT SCANNERS - MODELS V600, V1200 & V2400. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Visiscan (Irvine, US). The FDA issued a Cleared decision on October 3, 1986 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Visiscan devices

FDA 510(k) Submission Details - K861698

510(k) Number K861698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1986
Decision Date October 03, 1986
Days to Decision 151 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 107d · This submission: 151d
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 759
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K861698.
CT9800 QUICK 3D #B7919DA
K871859 · General Electric Co. · Aug 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
SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC
K861708 · General Electric Co. · Aug 1986
TECHNICARE 720 HPS CT SCANNER
K854340 · Technicare Corp. · Nov 1985
TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS
K853444 · Toshiba Medical Systems · Nov 1985