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Sonoace R7 Diagnostic Ultrasound System

by Samsung Medison Co., Ltd.

510(k) K133505

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 24 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08806167744953 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK133505 Date27 Dec 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Generic Name
General-purpose ultrasound imaging system
Model / Reference
USS-SAR7E3U/US
Primary DI / UDI-DI
08806167744953
510(k) Number
FDA Product Code
IYN, ITX, IYO
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class II
Regulation
21 CFR Part 892.1550 510(k)GUDID
892.1570 GUDID
892.1560 GUDID
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription Use
  • Serial Number

Other properties (12)

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