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Sonalis 209876

by Best Nomos

Sonalis 209876 is a Class II device made by Best Nomos, cleared under FDA 510(k) K100204 on 19 Feb 2010 and listed in FDA GUDID since 31 Oct 2016 (UDI-DI 00852656007014), 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) K100204

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 Number00852656007014 UDI-DI Date31 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100204 Date19 Feb 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100204 decided 19 Feb 2010 Active
  • FDA GUDID UDI-DI 00852656007014 listed 31 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100204
  2. Listed FDA GUDID 00852656007014

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sonalis
Generic name
General-purpose ultrasound imaging system
Model / reference
209876
Primary DI / UDI-DI
00852656007014
510(k) Number
FDA product code
ITX, IYO
GMDN term
General-purpose ultrasound imaging system
Device class
Class II
Regulation number
892.1570, 892.1560
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose ultrasound imaging system

Similar devices in this category

Other devices filed under General-purpose ultrasound imaging system.

Other devices from Best Nomos

See all devices from Best Nomos →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)