Cleared Traditional

K042484 - NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER

K042484 is an FDA 510(k) clearance for NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER, manufactured by Nai Technology Products. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K042484 · Nai Technology Products · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
37d
Days
Class 2
Risk

K042484 is an FDA 510(k) clearance for the NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Nai Technology Products (Upland, US). The FDA issued a Cleared decision on October 20, 2004 after a review of 37 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 Nai Technology Products devices

FDA 510(k) Submission Details - K042484

510(k) Number K042484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date October 20, 2004
Days to Decision 37 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
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 26
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K042484.
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
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
ELK LASER FILM DIGITIZER
K984409 · Nishimoto Sangyo Co., Ltd. · Feb 1999