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SonoSite Edge P15000-13R

by Fujifilm Sonosite, Inc.

SonoSite Edge P15000-13R is a Class II device made by Fujifilm Sonosite, Inc., cleared under FDA 510(k) K133454 on 16 Dec 2013 and listed in FDA GUDID since 24 Oct 2017 (UDI-DI 00841517103170), 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) K133454

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 Number00841517103170 UDI-DI Date24 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK133454 Date16 Dec 2013IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133454 decided 16 Dec 2013 Active
  • FDA GUDID UDI-DI 00841517103170 listed 24 Oct 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133454
  2. Listed FDA GUDID 00841517103170

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SonoSite Edge
Generic name
General-purpose ultrasound imaging system
Model / Ref / Catalog
P15000-13R, P15000
Primary DI / UDI-DI
00841517103170
510(k) Number
FDA product code
IYN, ITX, IYO
GMDN term
General-purpose ultrasound imaging system
Device class
Class II
Regulation number
892.1550, 892.1570, 892.1560
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose ultrasound imaging system

Cleared under the same submission (K133454)

and 8 more cleared under K133454

Similar devices in this category

Other devices filed under General-purpose ultrasound imaging system.

Other devices from Fujifilm Sonosite, Inc.

See all devices from Fujifilm Sonosite, Inc. →

Properties

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