Cleared Traditional

K071546 - EOS

K071546 is an FDA 510(k) clearance for EOS, manufactured by Biospace Med. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K071546 · Biospace Med · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
104d
Days
Class 2
Risk

K071546 is an FDA 510(k) clearance for the EOS. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Biospace Med (Washington, US). The FDA issued a Cleared decision on September 18, 2007 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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.

FDA 510(k) Submission Details - K071546

510(k) Number K071546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2007
Decision Date September 18, 2007
Days to Decision 104 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 328
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K071546.
INTUITION, MODEL 0170
K073632 · Arcoma AB · Jan 2008
IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K
K072867 · Imix Adr Finland OY · Nov 2007
RAD VISION, MODELS E AND EU
K072659 · Almana Medical Imaging · Nov 2007
QUANTUM DIREX SYSTEM
K072010 · Quantum Medical Imaging, LLC · Aug 2007
PXS-810, PODIATRY X-RAY SYSTEM
K071392 · Source-Ray, Inc. · Aug 2007
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
K071401 · Imaging Dynamics Company , Ltd. · Jun 2007
K071546 · EOS
Download PDF FDA Summary Biospace Med