Cleared Traditional

K984409 - ELK LASER FILM DIGITIZER

K984409 is an FDA 510(k) clearance for ELK LASER FILM DIGITIZER, manufactured by Nishimoto Sangyo Co., Ltd.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K984409 · Nishimoto Sangyo Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
65d
Days
Class 2
Risk

K984409 is an FDA 510(k) clearance for the ELK LASER FILM DIGITIZER. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Nishimoto Sangyo Co., Ltd. (San Leandro, US). The FDA issued a Cleared decision on February 12, 1999 after a review of 65 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 Nishimoto Sangyo Co., Ltd. devices

FDA 510(k) Submission Details - K984409

510(k) Number K984409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1998
Decision Date February 12, 1999
Days to Decision 65 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 faster than avg
Panel avg: 107d · This submission: 65d
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 25
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K984409.
DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019
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K993597 · Vidar Systems Corp. · Dec 1999
CCD CAMERA, MODEL 9000
K990066 · Camtronics, Ltd. · Mar 1999
IMATION TRIMATIC DIGITAL SYSTEM
K984252 · Imation Corp. · Jan 1999
FILM DIGITIZER MODEL 2905
K982785 · Array Corp. · Oct 1998
KONICA DIRECT DIGITIZER REGIUS MODEL 330
K980873 · Konica Corp. · Jun 1998