Cleared Traditional

K980213 - DI-2000

K980213 is an FDA 510(k) clearance for DI-2000, manufactured by Lumisys, Inc.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K980213 · Lumisys, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
67d
Days
Class 2
Risk

K980213 is an FDA 510(k) clearance for the DI-2000. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Lumisys, Inc. (Tucson, US). The FDA issued a Cleared decision on March 17, 1998 after a review of 67 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.

View all Lumisys, Inc. devices

FDA 510(k) Submission Details - K980213

510(k) Number K980213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1998
Decision Date March 17, 1998
Days to Decision 67 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
40d faster than avg
Panel avg: 107d · This submission: 67d
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 14
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K980213.
LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
K980809 · Lumisys, Inc. · May 1998
VIDAR VXR LS LASER FILM DIGITIZER
K974315 · Vidar Systems Corp. · Apr 1998
LD2000 SERIES
K980565 · General Scanning, Inc. · Mar 1998
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM
K974619 · Afp Imaging Corp. · Feb 1998
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
K973411 · General Scanning, Inc. · Dec 1997
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM
K971894 · Eastman Kodak Company · Aug 1997