Skip to content

Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU)

by Sonoscape Medical Corp.

510(k) K252498Model X11 Exp

Active European Union and United States. Also listed in GUDID (US).

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) K252498↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06945868610159 UDI-DI Date17 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK252498 Date5 Dec 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number69458686U1024SM Basic UDI-DI Date13 May 2025RegisteredStatusActive

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
X11 Pro EUDAMED
SU11B Ad EUDAMED
SU11B Cu EUDAMED
E10 Pro EUDAMED
X10 Elite EUDAMED
X10 Super EUDAMED
SonoScape GUDID
Generic Name
General-purpose ultrasound imaging system
Model / Reference
X11 Exp EUDAMED
SU11B CU GUDID
SU11B AD GUDID
E10 Pro GUDID
X10 Super GUDID
X10 Elite GUDID
X11 Pro GUDID
Primary DI / UDI-DI
06945868610159, 06945868610845, 06945868610852, 06945868610777, 06945868610654, 06945868610685
Basic UDI-DI
69458686U1024SM
510(k) Number
FDA Product Code
IYN, ITX, IYO
EMDN Code
Z11040103 Portable ultrasound scanners
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 892.1550 510(k)GUDID
892.1570 GUDID
892.1560 GUDID
EU market of registration
Netherlands
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
X11 Exp
510(k)
—
GUDID
SU11B CU
SU11B AD
E10 Pro
X10 Super
X10 Elite
X11 Pro
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
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.

The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging device designed for diagnostic imaging. It combines traditional grayscale ultrasound with color Doppler functionality to visualize blood flow and tissue structures, enabling assessment of vascular conditions, organ perfusion, and soft tissue abnormalities.

This system is intended for use in clinical, portable, and trolley-based settings by trained healthcare professionals. Supplied as a reusable medical device, it is regulated under FDA 510(k) clearance (K252498) and EU MDR. Models include variations such as X11, X10, and SU11 series, each tailored for specific diagnostic applications. Storage and handling follow standard medical device protocols to ensure functionality and sterility.

Other devices from Sonoscape Medical Corp.

See all devices from Sonoscape Medical Corp. →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No