Cleared Special

K032681 - KONICA LASER IMAGER, MODEL DRYPRO MODEL 771

K032681 is an FDA 510(k) clearance for KONICA LASER IMAGER, manufactured by Konica Medical and Graphic Corporation. The device is a Class 2 Radiology device with product code LMC cleared through the Special 510(k) pathway after a 26-day FDA review.

K032681 · Konica Medical and Graphic Corporation · Radiology device
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Sep 2003
Decision
26d
Days
Class 2
Risk

K032681 is an FDA 510(k) clearance for the KONICA LASER IMAGER, MODEL DRYPRO MODEL 771. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Konica Medical and Graphic Corporation (Mie-Ken, JP). The FDA issued a Cleared decision on September 24, 2003 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K032681

510(k) Number K032681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2003
Decision Date September 24, 2003
Days to Decision 26 days
Submission Type Special
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
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

LMC Device Classification - Class 2, Special Controls

Product Code LMC Camera, Multi Format, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2040
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 - LMC Camera, Multi Format, Radiological

All 120
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K032681.
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K032681 · KONICA LASER IMAGER, MODEL DRYPRO MODEL 771
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