Cleared Traditional

K811723 - WHOLE BODY SCANNER

K811723 is an FDA 510(k) clearance for WHOLE BODY SCANNER, manufactured by Cgr Medical Corp.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K811723 · Cgr Medical Corp. · Radiology device
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Jul 1981
Decision
32d
Days
Class 2
Risk

K811723 is an FDA 510(k) clearance for the WHOLE BODY SCANNER. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Cgr Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1981 after a review of 32 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 Cgr Medical Corp. devices

FDA 510(k) Submission Details - K811723

510(k) Number K811723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1981
Decision Date July 20, 1981
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
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 645
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K811723.
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CT/T DATALINK-B7875 AA/B7875 AB
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DEHYDRATED BILE
K811358 · Acumedia Manufacturers, Inc. · May 1981
SCANNER, COMPUTERIZED TOMOGRAPHIC
K803181 · General Electric Co. · Jan 1981