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Cardiovascular Angiography System

by Allengers Medical Systems Limited

510(k) K220311Ref AMSL/UM/MAM-VENUS+/XX/10, AMSL/UM/MARS 65/XX/14Model MAM-VENUS+, MARS 80, MARS 65, MARS 50+, MARS 50, MARS 40, MARS 30, MARS 15

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

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) K220311↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-08904139700218 Basic UDI-DI Date22 Aug 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08904139700218 Basic UDI-DI Date22 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK220311 Date3 May 2022ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Trade Name
Allengers
Device Name
Mammography
HF X-Ray Machine (Radiography, Radiography/Fluoroscopy, Digital Radiography)
Model / Reference
MAM-VENUS+, AMSL/UM/MAM-VENUS+/XX/10, MARS 80, MARS 65, MARS 50+, MARS 50, MARS 40, MARS 30, MARS 15, AMSL/UM/MARS 65/XX/14
Primary DI / UDI-DI
08904139700218, 08904139700256
Basic UDI-DI
B-08904139700218, 89041397HFX-RAYVA
Direct Marketing DI
08904139700256
510(k) Number
FDA Product Code
OWB
EMDN Code
Z11030202, Z11030702, Z11031101
Device Class
Class IIb EUDAMED
Class II 510(k)
Regulation
21 CFR Part 892.1650
EU market of registration
Belgium
Austria
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIb
510(k)
Class II

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.

This device is an Interventional Fluoroscopic X-Ray System, designed for real-time imaging of the cardiovascular system. It provides high-resolution visualisation of blood vessels, coronary arteries, and cardiac chambers to guide diagnostic and therapeutic procedures such as angioplasty, stent placement, and catheter interventions.

The system is used in radiology settings for invasive cardiovascular procedures, offering fluoroscopic imaging with X-ray technology. It is supplied as a reusable medical device, adhering to FDA 510(k) clearance and EU MDR compliance. Multiple registration numbers and FEI identifiers confirm its regulatory status, with no specific sterility or MRI safety notes provided in the data. Storage and handling follow standard medical device protocols for reusable fluoroscopic equipment.

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Questions

AI-generated answers, 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.

  • What types of cardiovascular procedures can this angiography system guide, and how does it provide real-time imaging for them?

    This system is designed for real-time imaging of the cardiovascular system, enabling visualization of blood vessels, coronary arteries, and cardiac chambers. It guides procedures such as angioplasty, stent placement, and catheter interventions by providing high-resolution fluoroscopic X-ray imaging during invasive cardiovascular procedures in radiology settings.

  • Is this device single-use or reusable, and what storage guidelines should be followed?

    The Cardiovascular Angiography System is a reusable medical device. Storage and handling must follow standard protocols for reusable fluoroscopic equipment, as no specific sterility or MRI safety notes are provided in the data.

  • What regulatory pathways has this device undergone, and which organizations have approved or cleared it?

    The device has undergone FDA 510(k) clearance, adhering to the traditional review pathway under the Radiology advisory committee. It is also compliant with EU MDR (Medical Device Regulation) and has been filed under the product code OWB, with multiple registration numbers confirming its regulatory status.

  • Are there different models or sizes available for this angiography system?

    The provided data does not specify distinct models or sizes for the Cardiovascular Angiography System. However, the system is designed for general use in radiology settings for invasive cardiovascular procedures, so compatibility with standard fluoroscopic imaging protocols should be assumed.

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No