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SterEOS Workstation

by Biospace Med 3 variants

510(k) K080529

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080529 Date29 Aug 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The sterEOS Workstation functions as a PACS for musculoskeletal 2D X-ray images, enabling acceptance, transfer, display, storage, and digital processing. When paired with the Biospace EOS System, it provides interactive 3D measurement tools for spinal deformity and scoliosis analysis.

The device operates on off-the-shelf hardware using Windows XP and is intended to be used by trained medical personnel, physicians, and technologists. It is a Class II X-ray system manufactured by Biospace Med and has received FDA 510(k) clearance.

Other devices from Biospace Med

  • Stereos Workstation

    Class II

  • Eos

    Class II

  • Stereos Workstation

    Class II

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the STEREOS Workstation used for?

    The STEREOS Workstation functions as a PACS for musculoskeletal 2D X-ray images, enabling acceptance, transfer, display, storage, and digital processing. When paired with the Biospace EOS System, it provides interactive 3D measurement tools for spinal deformity and scoliosis analysis, supporting trained medical personnel in diagnostic workflows.

  • How is the STEREOS Workstation supplied and operated?

    The device operates on off-the-shelf hardware using Windows XP and is intended for use by trained medical personnel, physicians, and technologists. It is supplied as a software-based PACS system that integrates with imaging hardware to manage and process musculoskeletal X-ray data.

  • Is the STEREOS Workstation a single-use or reusable device?

    The STEREOS Workstation is a reusable software system designed for repeated use in clinical environments. It is not a single-use device; instead, it is a Class II X-ray system intended for ongoing operation by trained personnel to support diagnostic imaging workflows over time.