Cleared Traditional

K973115 - ARRIPRO 35 ST/TV (FDA 510(k) Clearance)

Class I Radiology device.

K973115 · Arnold & Richter Cine Technik · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
13d
Days
Class 1
Risk

K973115 is an FDA 510(k) clearance for the ARRIPRO 35 ST/TV. Classified as Illuminator, Radiographic-film (product code IXC), Class I - General Controls.

Submitted by Arnold & Richter Cine Technik (Munich, DE). The FDA issued a Cleared decision on September 2, 1997 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1890 - 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 Arnold & Richter Cine Technik devices

Submission Details

510(k) Number K973115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1997
Decision Date September 02, 1997
Days to Decision 13 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code IXC Illuminator, Radiographic-film
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1890
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.