Cleared Traditional

K781936 - SCANNER-EMI 7020 AND 7020R

K781936 is an FDA 510(k) clearance for SCANNER-EMI 7020 AND 7020R, manufactured by Emi Medical, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K781936 · Emi Medical, Inc. · Radiology device
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Dec 1978
Decision
14d
Days
Class 2
Risk

K781936 is an FDA 510(k) clearance for the SCANNER-EMI 7020 AND 7020R. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Emi Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978 after a review of 14 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 Emi Medical, Inc. devices

FDA 510(k) Submission Details - K781936

510(k) Number K781936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1978
Decision Date December 04, 1978
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
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 K781936.
RADVIEW IMAGER SYSTEM
K790942 · General Electric Co. · Jun 1979
SOMATOM SD
K790342 · Siemens Corp. · Mar 1979
RADIOTHERAPY TREATMENT
K790134 · General Electric Co. · Feb 1979
ELECTRIC CT/T OPERATOR DISPLAY CONSOLE
K781431 · General Electric Co. · Sep 1978
CT SCANNER ND 8000
K781040 · Cgr Medical Corp. · Jul 1978
CT/T INDEPENDENT DIAGNOSTIC CENTER
K780480 · General Electric Co. · Apr 1978