Cleared Traditional

K003778 - BREAST-BOARD (MULTIPLE)

K003778 is an FDA 510(k) clearance for BREAST-BOARD (MULTIPLE), manufactured by Arplay Medical S.A.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K003778 · Arplay Medical S.A. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
183d
Days
Class 2
Risk

K003778 is an FDA 510(k) clearance for the BREAST-BOARD (MULTIPLE). Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Arplay Medical S.A. (Izeure, Cote D'Or, FR). The FDA issued a Cleared decision on June 8, 2001 after a review of 183 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 - K003778

510(k) Number K003778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2000
Decision Date June 08, 2001
Days to Decision 183 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
76d slower than avg
Panel avg: 107d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 724
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K003778.
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K003779 · Arplay Medical S.A. · Jul 2001
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K010916 · Ptw-New York Corp. · Jun 2001
RADCALC, MODEL V.4.0
K010464 · Lifeline Software, Inc. · May 2001
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50
K010472 · Thomson & Nielsen Electronics, Ltd. · May 2001
IVD (IN VIVO DOSIMETER), MODEL 1131
K010449 · Sun Nuclear Corp. · May 2001
K003778 · BREAST-BOARD (MULTIPLE)
Download PDF FDA Summary Arplay Medical S.A.