Cleared Traditional

K132261 - DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132261 · Ge Medical Systems, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
122d
Days
Class 2
Risk

K132261 is an FDA 510(k) clearance for the DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS). Classified as System, X-ray, Tomographic (product code IZF), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on November 18, 2013 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1740 - 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 Ge Medical Systems, LLC devices

Submission Details

510(k) Number K132261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2013
Decision Date November 18, 2013
Days to Decision 122 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 107d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZF System, X-ray, Tomographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1740
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 - IZF System, X-ray, Tomographic

All 41
Devices cleared under the same product code (IZF) and FDA review panel - the closest regulatory comparables to K132261.
TAP2D
K252649 · Nano-X Imaging , Ltd. · Feb 2026
Adaptix Ortho350
K252133 · Adaptix Limited · Nov 2025
Nanox.ARC X
K250850 · Nano-X Imaging , Ltd. · Apr 2025
Nanox.ARC
K242395 · Nano-X Imaging , Ltd. · Dec 2024
Nanox.ARC
K222934 · Nano-X Imaging , Ltd. · Apr 2023
Ortho Device, ADAPTIX 3D Orthopedic Imaging System
K221949 · Pausch Medical GmbH · Jan 2023