Cleared Traditional

K850416 - TOMOMATIC 564

K850416 is an FDA 510(k) clearance for TOMOMATIC 564, manufactured by M.I.D., Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K850416 · M.I.D., Inc. · Radiology device
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Sep 1985
Decision
228d
Days
Class 2
Risk

K850416 is an FDA 510(k) clearance for the TOMOMATIC 564. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by M.I.D., Inc. (Irvine, US). The FDA issued a Cleared decision on September 20, 1985 after a review of 228 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 M.I.D., Inc. devices

FDA 510(k) Submission Details - K850416

510(k) Number K850416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1985
Decision Date September 20, 1985
Days to Decision 228 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 107d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 397
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K850416.
ADAC VIEWPOINT (ADDITIONAL SOFTWARE)
K884349 · Adac Laboratories · Dec 1988
SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION
K875378 · Shimadzu Precision Instruments, Inc. · Nov 1988
NON-CIRCULAR ORBITING OPTION
K861252 · Siemens Gammasonics, Inc. · Apr 1986
GE RT/PLAN MAGNETIC TAPE DRIVE OPTION
K802801 · General Electric Co. · Jan 1981
ADAC TOMOGRAPHY OPTION
K791055 · Adac Laboratories · Sep 1979
RADIONUCLIDE COMPUTED TOMOGRAPHY SYS.
K770220 · G.D. Searle and Co. · Feb 1977