Cleared Traditional

K081121 - MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM

K081121 is an FDA 510(k) clearance for MODIFICATION TO ACUSON X150 ULTRASOUND ..., manufactured by Siemens Medical Solutions USA, Inc., Ultrasound DI. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K081121 · Siemens Medical Solutions USA, Inc., Ultrasound DI · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
44d
Days
Class 2
Risk

K081121 is an FDA 510(k) clearance for the MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc., Ultrasound DI (Mountainview, US). The FDA issued a Cleared decision on June 4, 2008 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 - K081121

510(k) Number K081121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2008
Decision Date June 04, 2008
Days to Decision 44 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
63d faster than avg
Panel avg: 107d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

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K081121 · MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM
Download PDF FDA Summary Siemens Medical Solut…