Cleared Traditional

K060737 - SINMED POSITIONING DEVICES

K060737 is an FDA 510(k) clearance for SINMED POSITIONING DEVICES, manufactured by Sinmed BV. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K060737 · Sinmed BV · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
11d
Days
Class 2
Risk

K060737 is an FDA 510(k) clearance for the SINMED POSITIONING DEVICES. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Sinmed BV (Reeuwijk, NL). The FDA issued a Cleared decision on March 31, 2006 after a review of 11 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K060737

510(k) Number K060737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2006
Decision Date March 31, 2006
Days to Decision 11 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 107d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Kema Quality B.V.
J.A. VAN VUGT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K060737.
TRILOGY RADIOTHERAPY DELIVERY SYSTEM
K061140 · Varian Medical Systems · May 2006
COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0
K060633 · Siemens Medical Solutions USA, Inc. · May 2006
MODIFICATION TO: HI-ART SYSTEM
K060912 · Tomotherapy Incorporated · Apr 2006
ONCOR EXPRESSION
K060226 · Siemens Medical Solutions USA, Inc. · Mar 2006
MIGUE
K052212 · Direx Systems Corp. · Mar 2006
DART-12
K052705 · Direx Systems Corp. · Feb 2006
K060737 · SINMED POSITIONING DEVICES
Download PDF FDA Summary Sinmed BV