Cleared Traditional

K001841 - 35/CD CINECONVERTER

K001841 is an FDA 510(k) clearance for 35/CD CINECONVERTER, manufactured by Tagarno A/S. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K001841 · Tagarno A/S · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
149d
Days
Class 2
Risk

K001841 is an FDA 510(k) clearance for the 35/CD CINECONVERTER. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Tagarno A/S (Horsens, DK). The FDA issued a Cleared decision on November 15, 2000 after a review of 149 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K001841

510(k) Number K001841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2000
Decision Date November 15, 2000
Days to Decision 149 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 107d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - LMA Digitizer, Image, Radiological

All 60
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K001841.
EFILM VIDEO
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LIFEJET VIDEO LINK
K013395 · Ferrania S.P.A. · Oct 2001
EXPRESSSUITE
K011049 · Vidar Systems Corp. · Oct 2001
CHILI VIDEO, CHILI VIDEOPRO
K000411 · Steinbeis-Transferzentrum Medizinische Informatik · Apr 2000
IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM
K992467 · Dba Systems, Inc. · Feb 2000
MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205
K993598 · Vidar Systems Corp. · Jan 2000
K001841 · 35/CD CINECONVERTER
Download PDF FDA Summary Tagarno A/S