Cleared Traditional

SCANNING DIRECTOR (K944585) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K944585 · Prentke Romich Co. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
155d
Days
Class 2
Risk

K944585 is an FDA 510(k) clearance for the SCANNING DIRECTOR. Classified as System, Environmental Control, Powered (product code IQA), Class II - Special Controls.

Submitted by Prentke Romich Co. (Wooster, US). The FDA issued a Cleared decision on February 21, 1995 after a review of 155 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3725 - the FDA physical medicine 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Prentke Romich Co. devices

Submission Details

510(k) Number K944585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1994
Decision Date February 21, 1995
Days to Decision 155 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 115d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IQA System, Environmental Control, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3725
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 Physical Medicine devices follow this clearance model.