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AI-Rad Companion (Pulmonary)

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K213713Ref 11665780Model MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT-Pulmo

by Siemens Healthcare GmbH

Identity

Trade Name
AI-Rad Companion (Pulmonary) EUDAMEDFDA UDI
Generic Name
CT system application software FDA UDI
Device Name
MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT-Pulmo EUDAMED
Model / Reference
11665780 EUDAMEDFDA UDI
MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT-Pulmo EUDAMED

Identifiers

Primary DI / UDI-DI
04056869996172 EUDAMEDFDA UDI
Basic UDI-DI
0405686902222V5 EUDAMED
510(k) Number
K213713 FDA 510(k)
K233753 FDA UDI
FDA Product Code
JAK FDA 510(k)FDA UDI
QIH FDA UDI
EMDN Code
Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
GMDN Term
CT system application software FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)FDA UDI
892.2050 FDA UDI
Special Device Type
Software EUDAMED
Market of Registration
Germany EUDAMED
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

AI-Rad Companion (Pulmonary) is an AI-enabled image processing software designed for quantitative and qualitative analysis of chest CT scans. It automates measurements and generates clinical images and reports to assist radiologists and physicians in interpreting pulmonary imaging data.

The device operates as a standalone software solution, analyzing previously acquired DICOM-formatted CT images. It is supplied as a digital tool for use in radiology departments, requiring no physical sterilization or single-use considerations. Authorized under FDA 510(k) clearance and MDR compliance, it supports diagnostic workflows without MRI safety constraints. No specific size or storage requirements are noted beyond standard IT infrastructure.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AI-Rad Companion - Siemens Healthineers, AI-Rad Companion (Pulmonary) Review: Pricing, FDA Status & Alternatives ..., Siemens Healthcare GmbH: AI-Rad Companion (Pulmonary) (FDA-cleared AI ..., PDF March 21, 2024 Siemens Healthcare GmbH Siemens Medical Solutions USA ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Siemens Healthcare GmbH

Sources (3)

  • FDA 510(k) K213713 24 fields · synced Oct 6, 2026
  • FDA UDI 385120b0-6139-4047-83a6-4ddec047101d 34 fields · synced May 30, 2026
  • EUDAMED 2be1dfe8-50a5-4b0e-bff0-aaec526af565 61 fields · synced Jul 18, 2026