Cleared Traditional

K771990 - OMNIMEDICAL 400L

K771990 is an FDA 510(k) clearance for OMNIMEDICAL 400L, manufactured by Omnimedical Services, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K771990 · Omnimedical Services, Inc. · Radiology device
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Nov 1977
Decision
42d
Days
Class 2
Risk

K771990 is an FDA 510(k) clearance for the OMNIMEDICAL 400L. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Omnimedical Services, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 30, 1977 after a review of 42 days - a notably fast clearance cycle.

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: 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 Omnimedical Services, Inc. devices

FDA 510(k) Submission Details - K771990

510(k) Number K771990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1977
Decision Date November 30, 1977
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

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 762
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K771990.
CT/T SYSTEM MODEL B7800A
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K772291 · Pfizer, Inc. · Dec 1977
CT SCANNER DIAGNOSTIC CONSOLE, REMOTE
K772198 · Varian Assoc., Inc. · Dec 1977
TOMOGRAPHIC SYSTEM, COMPUTERIZED
K772123 · Philips Medical Systems (Cleveland), Inc. · Nov 1977
SYNERVIEW MODEL 6478
K770855 · Philips Medical Systems (Cleveland), Inc. · May 1977
PHO. TRAX MODEL 4000 WHOLE BODY SCAN.
K760808 · G.D. Searle and Co. · Nov 1976