Cleared Traditional

K993598 - MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205

K993598 is an FDA 510(k) clearance for MAMMOGRAPHY PRO, manufactured by Vidar Systems Corp.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K993598 · Vidar Systems Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
87d
Days
Class 2
Risk

K993598 is an FDA 510(k) clearance for the MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Vidar Systems Corp. (Herndon, US). The FDA issued a Cleared decision on January 20, 2000 after a review of 87 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 - K993598

510(k) Number K993598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1999
Decision Date January 20, 2000
Days to Decision 87 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
20d faster than avg
Panel avg: 107d · This submission: 87d
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 56
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K993598.
35/CD CINECONVERTER
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IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM
K992467 · Dba Systems, Inc. · Feb 2000
DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019
K993599 · Vidar Systems Corp. · Jan 2000
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617
K993597 · Vidar Systems Corp. · Dec 1999
CCD CAMERA, MODEL 9000
K990066 · Camtronics, Ltd. · Mar 1999
K993598 · MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205
Download PDF FDA Summary Vidar Systems Corp.