Cleared Traditional

K032022 - DIGITAL IMAGER

K032022 is an FDA 510(k) clearance for DIGITAL IMAGER, manufactured by Pyramid Medical, Inc.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K032022 · Pyramid Medical, Inc. · Radiology device
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Sep 2003
Decision
64d
Days
Class 2
Risk

K032022 is an FDA 510(k) clearance for the DIGITAL IMAGER. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Pyramid Medical, Inc. (Los Alamitos, US). The FDA issued a Cleared decision on September 2, 2003 after a review of 64 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 - K032022

510(k) Number K032022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2003
Decision Date September 02, 2003
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
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 K032022.
FILM DIGITZER, MODEL 2908 MAMMO PRO
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NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER
K042484 · Nai Technology Products · Oct 2004
MEDICAL IMAGE DIGITIZER, MODEL 2908
K033637 · Array Corp. · Dec 2003
COBRASCAN CR-1 FILMLESS
K022810 · Radiographic Digital Imaging, Inc. · Oct 2002
FULCRUM
K021949 · Howtek, Inc. · Aug 2002
LASERPRO 16
K020243 · Eradlink, Inc. · Mar 2002
K032022 · DIGITAL IMAGER
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