Skip to content

Synapse MIP/MPR Image Visualization Software Obliquus

by Fujifilm Medical Systems U.S.A, Inc.

510(k) K061672

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 NumberK061672 Date29 Jun 2006ClearedStatusActive

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  • Withdrawn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.

Synapse MIP/MPR Image Visualization Software Obliquus is a software device intended for the display of 3D multiplanar reconstruction (MPR) and maximum intensity projection (MIP) visualization of CT and MR studies. It enables the visualization of medical imaging data for diagnostic review.

The software is supplied as a non-sterile, reusable software application intended for use in radiology settings by radiologists, technologists, and clinicians. It operates on standard PACS workstations and is authorized under FDA 510(k) clearance K061672 with product code LLZ.

Other devices from Fujifilm Medical System U.S.A., Inc.

See all devices from Fujifilm Medical System U.S.A., Inc. →

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 Synapse MIP/MPR Image Visualization Software Obliquus used for?

    It is intended for the display of 3D multiplanar reconstruction (MPR) and maximum intensity projection (MIP) visualizations of CT and MR studies, enabling diagnostic review of medical imaging data by radiologists, technologists, and clinicians.

  • How is the Synapse MIP/MPR Image Visualization Software Obliquus supplied and is it reusable?

    The software is supplied as a non-sterile, reusable software application designed for use on standard PACS workstations in radiology settings, allowing repeated use without degradation of function.

  • What regulatory authorization does the Synapse MIP/MPR Image Visualization Software Obliquus have?

    It is authorized under FDA 510(k) clearance K061672 with product code LLZ, determined to be substantially equivalent to a predicate device through a traditional review process.