Cleared Traditional

K882175 - HR-2000 W/SUFFIXES B

K882175 is an FDA 510(k) clearance for HR-2000 W/SUFFIXES B, manufactured by Eigen. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K882175 · Eigen · Radiology device
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Aug 1988
Decision
87d
Days
Class 2
Risk

K882175 is an FDA 510(k) clearance for the HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Eigen (Nevada City, US). The FDA issued a Cleared decision on August 19, 1988 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Eigen devices

FDA 510(k) Submission Details - K882175

510(k) Number K882175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1988
Decision Date August 19, 1988
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 150
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