Cleared Traditional

K080529 - STEREOS WORKSTATION

K080529 is an FDA 510(k) clearance for STEREOS WORKSTATION, manufactured by Biospace Med. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K080529 · Biospace Med · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
185d
Days
Class 2
Risk

K080529 is an FDA 510(k) clearance for the STEREOS WORKSTATION. 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 Biospace Med (Washington, US). The FDA issued a Cleared decision on August 29, 2008 after a review of 185 days - an extended review 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 - K080529

510(k) Number K080529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2008
Decision Date August 29, 2008
Days to Decision 185 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
78d slower than avg
Panel avg: 107d · This submission: 185d
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 2257
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K080529.
Z3D CONTRAST ACUITY
K080196 · Clario Medical Imaging, Inc. · Sep 2008
5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9)
K081357 · Eizo GmbH · Sep 2008
AMICAS PACS, VERSION 6.0
K082144 · Amicas, Inc. · Sep 2008
DSA 2000EX
K082341 · Eigen, LLC · Aug 2008
VOLUMINA
K081215 · Kjaya Medical, LLC · Aug 2008
CENTRICITY PACS IW
K082318 · Ge Healthcare Dynamic Imaging Solutions · Aug 2008
K080529 · STEREOS WORKSTATION
Download PDF FDA Summary Biospace Med