Cleared Traditional

K853482 - ACE COMPUTER SYSTEM

K853482 is an FDA 510(k) clearance for ACE COMPUTER SYSTEM, manufactured by Cardiac Medical Systems Corp.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K853482 · Cardiac Medical Systems Corp. · Radiology device
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Jan 1986
Decision
134d
Days
Class 1
Risk

K853482 is an FDA 510(k) clearance for the ACE COMPUTER SYSTEM. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Cardiac Medical Systems Corp. (Springfield, US). The FDA issued a Cleared decision on January 1, 1986 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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 Cardiac Medical Systems Corp. devices

FDA 510(k) Submission Details - K853482

510(k) Number K853482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1985
Decision Date January 01, 1986
Days to Decision 134 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

IYX Device Classification - Class 1, General Controls

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 90
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K853482.
BODYSCAN
K870818 · Siemens Gammasonics, Inc. · Mar 1987
WEIGHTED ACQUISITION MODULE
K861637 · Siemens Gammasonics, Inc. · Jun 1986
STARPORT MODEL H3300AA
K852648 · General Electric Co. · Jan 1986
JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2
K853470 · Toshiba Medical Systems · Nov 1985
SATURN NUCLEAR MEDICINE COMPUTER SYSTEM
K852089 · Technicare Corp. · Jul 1985
BASICAM COUNTER BALANCE CAMERA
K850463 · Siemens Gammasonics, Inc. · Apr 1985