Cleared Traditional

K882176 - VTR-12

K882176 is an FDA 510(k) clearance for VTR-12, manufactured by Eigen. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K882176 · Eigen · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
79d
Days
Class 2
Risk

K882176 is an FDA 510(k) clearance for the VTR-12. 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 11, 1988 after a review of 79 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 - K882176

510(k) Number K882176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1988
Decision Date August 11, 1988
Days to Decision 79 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 107d · This submission: 79d
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
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K882176.
ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
K883372 · Ausonics Pty , Ltd. · Nov 1988
CARDIAC CX
K883985 · Fischer Imaging Corp. · Nov 1988
SHIMADZU LATERAL C-ARM MH-31
K882311 · Shimadzu Precision Instruments, Inc. · Sep 1988
CEILING MOUNTED FLUOROSCOPIC C-ARM ARIEL C-ARM
K880527 · Fischer Imaging Corp. · Feb 1988
REVELATION, RADIO FLUOROSCOPIC X-RAY EXAM TABLE
K874901 · Fischer Imaging Corp. · Jan 1988
SHIMADZU CATHETERIZATION C-ARM STAND MH-50A
K875157 · Shimadzu Precision Instruments, Inc. · Jan 1988