Cleared Traditional

K912073 - POLAROID HELIOS LASER IMAGER

K912073 is an FDA 510(k) clearance for POLAROID HELIOS LASER IMAGER, manufactured by Polaroid Medical Corp.. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K912073 · Polaroid Medical Corp. · Radiology device
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Aug 1991
Decision
110d
Days
Class 2
Risk

K912073 is an FDA 510(k) clearance for the POLAROID HELIOS LASER IMAGER. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Polaroid Medical Corp. (Washington, US). The FDA issued a Cleared decision on August 28, 1991 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Polaroid Medical Corp. devices

FDA 510(k) Submission Details - K912073

510(k) Number K912073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1991
Decision Date August 28, 1991
Days to Decision 110 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
3d slower than avg
Panel avg: 107d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 76
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K912073.
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