Cleared Traditional

K013395 - LIFEJET VIDEO LINK

K013395 is an FDA 510(k) clearance for LIFEJET VIDEO LINK, manufactured by Ferrania S.P.A.. 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.

K013395 · Ferrania S.P.A. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
15d
Days
Class 2
Risk

K013395 is an FDA 510(k) clearance for the LIFEJET VIDEO LINK. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Ferrania S.P.A. (Ferrania, Savona, IT). The FDA issued a Cleared decision on October 30, 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 - K013395

510(k) Number K013395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date October 30, 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

Underwriters Laboratories, Inc.
CHANTEL CARSON

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 K013395.
FULCRUM
K021949 · Howtek, Inc. · Aug 2002
LASERPRO 16
K020243 · Eradlink, Inc. · Mar 2002
EFILM VIDEO
K013631 · Efilm Medical, Inc. · Nov 2001
EXPRESSSUITE
K011049 · Vidar Systems Corp. · Oct 2001
35/CD CINECONVERTER
K001841 · Tagarno A/S · Nov 2000
CHILI VIDEO, CHILI VIDEOPRO
K000411 · Steinbeis-Transferzentrum Medizinische Informatik · Apr 2000
K013395 · LIFEJET VIDEO LINK
Download PDF FDA Summary Ferrania S.P.A.