Cleared Traditional

K973115 - ARRIPRO 35 ST/TV

K973115 is an FDA 510(k) clearance for ARRIPRO 35 ST/TV, manufactured by Arnold & Richter Cine Technik. The device is a Class 1 Radiology device with product code IXC cleared through the Traditional 510(k) pathway after a 13-day FDA review.

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

FDA 510(k) Submission Details - K973115

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
Combination Product No
PCCP Authorized No
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.

IXC Device Classification - Class 1, General Controls

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.

Regulatory Consultant

Tuv Product Service, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IXC Illuminator, Radiographic-film

Devices cleared under the same product code (IXC) and FDA review panel - the closest regulatory comparables to K973115.
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K954998 · Lily Imaging Solutions Co. · Jan 1996
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K872245 · General Electric Co. · Jun 1987
LF MOTORIZED RADIOGRAPHIC FILM VIEWER
K840607 · Sybron Corp. · Mar 1984