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SmartCT R1.0

by Philips Medical Systems Nederland B.V.

510(k) K201583

Active European Union and United States

CE MDR 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) K201583↗

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
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Abbreviated NumberK201583 Date9 Feb 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

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  • Withdrawn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 Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
OWB
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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 SmartCT R1.0 is an Interventional Fluoroscopic X-Ray System, designed for real-time imaging during minimally invasive procedures. It provides high-resolution visualisation to guide interventions such as angiography, biopsy, or ablation, ensuring precise operator control and patient safety in radiology settings.

This device is supplied as a reusable medical system, intended for use in clinical environments with appropriate sterilisation protocols. It is classified as Class 2 under FDA regulations (product code OWB) and complies with MDR standards. The system is authorised for FDA 510(k) clearance and MDR, with MRI safety considerations noted in its specifications. Storage and handling follow standard radiology protocols to maintain performance and sterility.

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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 procedures is the SmartCT R1.0 designed to support in real-time imaging?

    The SmartCT R1.0 is specifically designed for real-time imaging during minimally invasive procedures such as angiography, biopsy, and ablation. Its high-resolution fluoroscopic capabilities provide precise visualization to guide operators, ensuring accuracy and patient safety in radiology settings.

  • Is the SmartCT R1.0 a single-use or reusable device, and what sterilization protocols should be followed?

    The SmartCT R1.0 is a reusable medical system, intended for use in clinical environments. It must be handled and sterilized according to standard radiology protocols to maintain performance and ensure sterility between uses.

  • What regulatory pathways has the SmartCT R1.0 undergone, and what classification does it hold?

    The SmartCT R1.0 has received FDA 510(k) clearance and complies with the Medical Device Regulation (MDR). It is classified as a Class 2 device under FDA regulations with the product code OWB, indicating it has undergone substantial equivalence review by the Radiology (RA) advisory committee.

  • Does the SmartCT R1.0 have any specific MRI safety considerations mentioned in its specifications?

    Yes, the SmartCT R1.0 includes MRI safety considerations in its specifications, which should be reviewed and followed to ensure safe operation in environments where MRI equipment is present.

  • How should the SmartCT R1.0 be stored and handled to maintain its performance?

    The SmartCT R1.0 follows standard radiology protocols for storage and handling to preserve its performance and sterility. This includes proper environmental conditions, maintenance routines, and adherence to manufacturer guidelines to ensure optimal functionality and safety.