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Rayvolve PTX-PE

by Azmed

510(k) K243808

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243808↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK243808 Date21 Mar 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243808 decided 21 Mar 2025 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
QFM
Device class
Class II
Regulation
21 CFR Part 892.2080
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 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 Rayvolve PTX-PE is a Radiological Computer-Assisted Prioritization Software for Lesions, designed to assist radiologists in evaluating and prioritising pulmonary nodules and other lesions within chest imaging studies. This Class II device leverages AI-driven algorithms to enhance diagnostic workflows by identifying and stratifying findings based on predefined risk criteria, thereby supporting more efficient and standardised assessments in radiology.

Supplied as a software application, the Rayvolve PTX-PE operates within a clinical radiology setting and is intended for single-use per imaging session, though its software licence may allow repeated use across multiple studies. Authorised under FDA 510(k) and MDR, it adheres to regulatory standards for medical imaging software, with no specific sterility or reusable components. The device is non-invasive, MRI-safe, and does not require physical storage beyond the facility’s IT infrastructure. Its registration numbers include multiple FEI identifiers (e.g., 3034205378) under the QFM product code, reflecting its classification as a diagnostic imaging aid.

Similar devices

Other devices filed under FDA product code QFM (Radiological Computer-Assisted Prioritization Software For Lesions).

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