Cleared Traditional

ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW (K932508) - FDA 510(k) Clearance

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

K932508 · Elscint, Inc. · Radiology device
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Jul 1994
Decision
430d
Days
Class 2
Risk

K932508 is an FDA 510(k) clearance for the ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on July 29, 1994 after a review of 430 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Elscint, Inc. devices

Submission Details

510(k) Number K932508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1993
Decision Date July 29, 1994
Days to Decision 430 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
323d slower than avg
Panel avg: 107d · This submission: 430d
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 421
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K932508.
PQ5000 CT SYSTEM
K943623 · Philips Medical Systems (Cleveland), Inc. · Apr 1995
CT PROSPEED FAMILY
K944013 · GE Medical Systems · Feb 1995
HISPEED ADVANTAGE II
K940606 · GE Medical Systems · Aug 1994
TSX-002A (XVISION) CT SCANNER
K941745 · Toshiba America Medical Systems, In.C · Jul 1994
VOLUMETRIC RENDERING TECHNIQUE OPTION
K923524 · Siemens Medical Solutions USA, Inc. · May 1994
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K924985 · Siemens Medical Solutions USA, Inc. · Apr 1994