Cleared Traditional

K833484 - COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC

K833484 is an FDA 510(k) clearance for COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC, manufactured by A. Patil, M.D.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K833484 · A. Patil, M.D. · Neurology device
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Dec 1983
Decision
83d
Days
Class 2
Risk

K833484 is an FDA 510(k) clearance for the COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by A. Patil, M.D. (Minot, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device 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 A. Patil, M.D. devices

FDA 510(k) Submission Details - K833484

510(k) Number K833484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1983
Decision Date December 29, 1983
Days to Decision 83 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 148d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 356
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