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P20 Series Digital Color Doppler Ultrasound System

by Sonoscape Medical Corp.

510(k) K172993

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) K172993↗

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 · Traditional NumberK172993 Date5 Dec 2017ClearedStatusActive
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  • Withdrawn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
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
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 P20 Series Digital Color Doppler Ultrasound System is a Class II medical imaging device classified as a Color Doppler Ultrasound Machine (FDA Product Code: IYN). It combines digital imaging technology with color Doppler functionality to visualize blood flow and tissue structures in real time, enabling diagnostic assessment across multiple specialties including obstetrics, gynecology, and general radiology.

This system is supplied as a multi-functional ultrasound console, available in various configurations (4/F, 5/F, 8/F, 9/F, and 10/F). It is intended for use in clinical radiology settings and has received FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent by the Radiology Advisory Committee. The device is not described as single-use or sterile; regulatory compliance also includes MDR requirements.

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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 clinical specialties is the P20 Series Digital Color Doppler Ultrasound System primarily used for, and why does this matter for my practice?

    The P20 Series is designed for diagnostic imaging in obstetrics, gynecology, and general radiology, leveraging its color Doppler functionality to visualize blood flow alongside tissue structures in real time. This matters because its versatility supports a wide range of applications—from fetal monitoring to vascular assessments—making it suitable for multi-specialty clinics or departments where ultrasound is a core modality. The multi-functional console configurations (4/F to 10/F) also allow flexibility in probe options, which may align with your practice’s specific imaging needs.

  • How is the P20 Series supplied, and what does the ‘4/F, 5/F, etc.’ labeling mean for my purchasing decision?

    The P20 Series is supplied as a multi-functional ultrasound console, with different configurations labeled by the number of transducer frequencies (F) it supports (e.g., 4/F, 5/F, 8/F, 9/F, 10/F). This indicates the variety of probes included or compatible with the system, which can affect imaging depth and resolution for different applications. For example, higher ‘F’ values (like 9/F or 10/F) may offer broader frequency ranges, useful for pediatric or superficial imaging, while lower values (like 4/F) might prioritize deeper tissue penetration. Choose based on your most common use cases.

  • Is the P20 Series Digital Color Doppler Ultrasound System reusable or single-use, and how does this impact maintenance or workflow?

    The P20 Series is not described as single-use or sterile, meaning it is designed for reusable clinical use in radiology settings. This implies standard maintenance protocols (e.g., cleaning, calibration) will apply, which may affect workflow planning. Reusability also typically reduces per-procedure costs but requires adherence to manufacturer guidelines for infection control and device longevity. Always confirm with the manufacturer’s instructions for your specific model configuration.

  • What regulatory pathways does the P20 Series follow, and how does this affect its use in my facility?

    The P20 Series has received FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent by the Radiology Advisory Committee (RA). It also complies with MDR (Medical Device Regulation) requirements. This means the device meets U.S. safety and performance standards for its intended use as a Color Doppler Ultrasound Machine (Product Code IYN) and can be legally marketed and used in clinical settings where such imaging is authorized. For international use, verify local compliance beyond these approvals.