Cleared Traditional

K030018 - MHS 7000

K030018 is an FDA 510(k) clearance for MHS 7000, manufactured by Micro Health Systems, Inc.. The device is a Class 1 Radiology device with product code LHQ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K030018 · Micro Health Systems, Inc. · Radiology device
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Mar 2003
Decision
83d
Days
Class 1
Risk

K030018 is an FDA 510(k) clearance for the MHS 7000. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Micro Health Systems, Inc. (Parkland, US). The FDA issued a Cleared decision on March 26, 2003 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2980 - 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 Micro Health Systems, Inc. devices

FDA 510(k) Submission Details - K030018

510(k) Number K030018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2003
Decision Date March 26, 2003
Days to Decision 83 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 107d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

LHQ Device Classification - Class 1, General Controls

Product Code LHQ System, Telethermographic (adjunctive Use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.2980
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 - LHQ System, Telethermographic (adjunctive Use)

All 29
Devices cleared under the same product code (LHQ) and FDA review panel - the closest regulatory comparables to K030018.
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