Cleared Traditional

K040931 - PATXFER RT

K040931 is an FDA 510(k) clearance for PATXFER RT, manufactured by Brainlab AG. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K040931 · Brainlab AG · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
104d
Days
Class 2
Risk

K040931 is an FDA 510(k) clearance for the PATXFER RT. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Brainlab AG (Heimstetten, DE). The FDA issued a Cleared decision on July 22, 2004 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 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Brainlab AG devices

FDA 510(k) Submission Details - K040931

510(k) Number K040931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2004
Decision Date July 22, 2004
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.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1192
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K040931.
FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP
K041990 · Fujifilm Medical System U.S.A., Inc. · Aug 2004
UNDECIDED
K041484 · Siemens Medical Solutions USA, Inc. · Jul 2004
CAAS MRV
K041682 · Pie Medical Imaging BV · Jul 2004
5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)
K041737 · Totoku Electric Co., Ltd. · Jul 2004
LEONARDO
K040970 · Siemens Medical Systems, Inc. · Jul 2004
KINETDX
K041029 · Siemens Medi Cal Solutions, Inc. · Jul 2004