Cleared Traditional

K935694 - SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE

K935694 is an FDA 510(k) clearance for SIENET DIAGNOSTIC REPORTING CONSOLE VA0..., manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K935694 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
98d
Days
Class 2
Risk

K935694 is an FDA 510(k) clearance for the SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE. 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 Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 98 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.

FDA 510(k) Submission Details - K935694

510(k) Number K935694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1993
Decision Date March 07, 1994
Days to Decision 98 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
9d faster than avg
Panel avg: 107d · This submission: 98d
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 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K935694.
ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW)
K941933 · I.S.G. Technologies, Inc. · Jul 1994
ALLEGRO VIEWING WAND
K911783 · I.S.G. Technologies, Inc. · Apr 1994
RADSTAT
K932564 · Dimensional Medicine, Inc. · Mar 1994
CEMAX CLINICALVIEW(TM) STATION AND/OR SOFTWARE
K932371 · Cemax, Inc. · Feb 1994
CEMAX VIPSTATION(TM) AND/OR SOFTWARE
K932372 · Cemax, Inc. · Nov 1993
VISIONTOOL
K933209 · Evergreen Technologies, Inc. · Sep 1993
K935694 · SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE
Download PDF FDA Summary Siemens Medical Solut…