Cleared Traditional

K013631 - EFILM VIDEO

K013631 is an FDA 510(k) clearance for EFILM VIDEO, manufactured by Efilm Medical, Inc.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K013631 · Efilm Medical, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
15d
Days
Class 2
Risk

K013631 is an FDA 510(k) clearance for the EFILM VIDEO. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Efilm Medical, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on November 20, 2001 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - 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.

FDA 510(k) Submission Details - K013631

510(k) Number K013631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2001
Decision Date November 20, 2001
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LMA Device Classification - Class 2, Special Controls

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
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 Consultant

Entela, Inc.
N.E. DEVINE JR.

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 - LMA Digitizer, Image, Radiological

All 60
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K013631.
COBRASCAN CR-1 FILMLESS
K022810 · Radiographic Digital Imaging, Inc. · Oct 2002
FULCRUM
K021949 · Howtek, Inc. · Aug 2002
LASERPRO 16
K020243 · Eradlink, Inc. · Mar 2002
LIFEJET VIDEO LINK
K013395 · Ferrania S.P.A. · Oct 2001
EXPRESSSUITE
K011049 · Vidar Systems Corp. · Oct 2001
35/CD CINECONVERTER
K001841 · Tagarno A/S · Nov 2000
K013631 · EFILM VIDEO
Download PDF FDA Summary Efilm Medical, Inc.