Cleared Traditional

K803312 - MICROMEDIC AUTOMATIC COMPUTING CENTER

K803312 is an FDA 510(k) clearance for MICROMEDIC AUTOMATIC COMPUTING CENTER, manufactured by Micomedic Systems. The device is a Class 1 Radiology device with product code JQP cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K803312 · Micomedic Systems · Radiology device
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Feb 1981
Decision
33d
Days
Class 1
Risk

K803312 is an FDA 510(k) clearance for the MICROMEDIC AUTOMATIC COMPUTING CENTER. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Micomedic Systems (Mchenry, US). The FDA issued a Cleared decision on February 4, 1981 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 862.2100 - 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.

View all Micomedic Systems devices

FDA 510(k) Submission Details - K803312

510(k) Number K803312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1981
Decision Date February 04, 1981
Days to Decision 33 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 107d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

JQP Device Classification - Class 1, General Controls

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
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 - JQP Calculator/data Processing Module, For Clinical Use

All 56
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K803312.
715 DELTA TERMINAL
K821058 · Corning Medical & Scientific · May 1982
IL 8060 DATA MANAGEMENT SYSTEM
K820427 · Instrumentation Laboratory CO · Mar 1982
BCD-HPP41C INTERFACE
K810968 · Dynatech Corp. · Apr 1981
BECKMAN DP-5500 DATA REDUCTION SYSTEM
K802594 · Beckman Instruments, Inc. · Nov 1980
SP 120 SOPHISTICATE
K802251 · Vickers America Medical Corp. · Oct 1980
SERALYZER GLUCOSE TEST MODULE
K801664 · Miles Laboratories, Inc. · Aug 1980