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Shear Wave Quantificational Ultrasound Diagnostic System FH6000

by Wuxi Hisky Medical Technologies Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06971679949966 UDI-DI Date1 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Shear Wave Quantificational Ultrasound Diagnostic System
Generic Name
Hepatic ultrasound elastography system
Model / Reference
FH6000
Primary DI / UDI-DI
06971679949966
510(k) Number
FDA Product Code
IYN, IYO, ITX
GMDN Term
Hepatic ultrasound elastography system
Device Class
Class II
Regulation Number
892.1550, 892.1560, 892.1570
GUDID distribution status
In Commercial Distribution
Sterilization Method
Liquid Chemical
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K250026)

Other devices from Wuxi Hisky Medical Technologies Co., Ltd.

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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