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EndoSound® EVSScanner 5000

by Endosound, Inc.

EndoSound EVSScanner 5000 is a general-purpose ultrasound imaging system (FDA Class II) made by Endosound, Inc., cleared under FDA 510(k) K232518 on 27 Dec 2023 and listed in FDA GUDID since 30 Jan 2024 (UDI-DI 00850050934028), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K232518

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850050934028 UDI-DI Date30 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232518 Date27 Dec 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232518 decided 27 Dec 2023 Active
  • FDA GUDID UDI-DI 00850050934028 listed 30 Jan 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232518
  2. Listed FDA GUDID 00850050934028

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EndoSound® EVSScanner
Generic name
General-purpose ultrasound imaging system
Model / Ref / Catalog
5000
Primary DI / UDI-DI
00850050934028
510(k) Number
FDA product code
ODG, IYN, IYO
GMDN term
General-purpose ultrasound imaging system
Device class
Class II
Regulation number
876.1500, 892.1550, 892.1560
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose ultrasound imaging system

Cleared under the same submission (K232518)

and 8 more cleared under K232518

Similar devices in this category

Other devices filed under General-purpose ultrasound imaging system.

Other devices from Endosound, Inc.

See all devices from Endosound, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)