Cleared Traditional

K070954 - PATIENTGALLERY IMAGING SOFTWARE

K070954 is an FDA 510(k) clearance for PATIENTGALLERY IMAGING SOFTWARE, manufactured by Raster Builders, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K070954 · Raster Builders, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
15d
Days
Class 2
Risk

K070954 is an FDA 510(k) clearance for the PATIENTGALLERY IMAGING SOFTWARE. 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 Raster Builders, Inc. (Mill Valley, US). The FDA issued a Cleared decision on April 20, 2007 after a review of 15 days - a notably fast clearance cycle.

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.

FDA 510(k) Submission Details - K070954

510(k) Number K070954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2007
Decision Date April 20, 2007
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
MORTEN SIMON CHRISTENSEN

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 - LLZ System, Image Processing, Radiological

All 2284
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K070954.
SAPHENEIA CLARITY
K063391 · Sapheneia Commercial Products AB · Apr 2007
DICOMPACS, MODEL 5
K070618 · Oehm Und Rehbein GmbH · Apr 2007
VISIO+CD VIEWER# KPSCDVE01
K070606 · Keosys Sas · Apr 2007
DGSCOPE, RELEASE 1.0
K070397 · Segami Corporation · Apr 2007
MIRAGE CEDARS OPTION
K070683 · Segami Corporation · Apr 2007
QLAB QUANTIFICATION
K070792 · Philips Ultrasound, Inc. · Apr 2007
K070954 · PATIENTGALLERY IMAGING SOFTWARE
Download PDF FDA Summary Raster Builders, Inc.