Cleared Traditional

K904392 - MULTILAB 2000

K904392 is an FDA 510(k) clearance for MULTILAB 2000, manufactured by Unetixs, Inc.. The device is a Class 2 Radiology device with product code JAF cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K904392 · Unetixs, Inc. · Radiology device
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Apr 1991
Decision
217d
Days
Class 2
Risk

K904392 is an FDA 510(k) clearance for the MULTILAB 2000. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Unetixs, Inc. (Providence, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 217 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1540 - 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 Unetixs, Inc. devices

FDA 510(k) Submission Details - K904392

510(k) Number K904392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1990
Decision Date April 29, 1991
Days to Decision 217 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 107d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAF Device Classification - Class 2, Special Controls

Product Code JAF Monitor, Ultrasonic, Nonfetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1540
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 - JAF Monitor, Ultrasonic, Nonfetal

All 27
Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K904392.
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K854590 · Philips Medical Systems, Inc. · Apr 1986