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Multi-Modality Tumor Tracking (MMTT) Application

by Philips Medical Systems Nederland B.V.

510(k) K162955

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 NumberK162955 Date19 Dec 2016ClearedStatusActive

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  • Withdrawn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, 22 Sep 2026

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

Multi-Modality Tumor Tracking (MMTT) is a post-processing software application used to display, process, analyze and quantify anatomical and functional images for CT, MR, PET/CT, SPECT/CT and Dual Energy CT at one or multiple time points. It is a non-organ specific, multimodality application designed to function as an advanced visualization tool.

The application is supplied as software and is intended for use with medical imaging systems. It is not specified as single-use or reusable, and no information regarding sterility or MRI safety is provided. The device is authorized under FDA 510K clearance with product code LLZ and K-number K162955.

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Questions

AI-generated answers, 22 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 imaging modalities are supported by the Multi-Modality Tumor Tracking (MMTT) application?

    MMTT can import and work with anatomical and functional datasets from CT, MR, PET/CT, SPECT/CT and Dual Energy CT. By handling these modalities in a single environment, clinicians can compare structural and metabolic information without switching between separate workstations, which streamlines tumor assessment.

  • How is the MMTT application supplied and installed for use with imaging systems?

    The product is delivered as a software package that is installed on compatible medical imaging workstations. Installation follows the manufacturer’s standard software deployment procedures, and the application integrates with existing imaging systems to access DICOM data for processing and visualization.

  • Is the MMTT software considered single‑use or reusable, and does sterility apply?

    Software is inherently reusable; it can be launched repeatedly on the same workstation. Because it is not a physical device that contacts patients, sterility and MRI safety considerations are not applicable to this application.

  • What regulatory clearance does the Multi-Modality Tumor Tracking (MMTT) application have?

    MMTT received traditional FDA 510(k) clearance (product code LLZ, K‑number K162955) based on substantial equivalence to a predicate device. This clearance indicates that the software meets the FDA’s safety and effectiveness requirements for its intended use.

  • How does MMTT facilitate longitudinal analysis of tumor images?

    The software allows users to load images from one or multiple time points and provides tools to align, compare, and quantify changes in tumor size or functional activity over time. This capability supports treatment monitoring by highlighting progression or response across successive scans.