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Clisis Systems Ws

by General Medical Merate SpA

Clisis Systems Ws is a Class II device made by General Medical Merate SpA, cleared under FDA 510(k) K213081 on 26 Oct 2021 and listed in FDA GUDID since 11 Jul 2018 (UDI-DI 08054890480086), active as of 23 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 23 Oct 2026

Documents

510(k) K213081

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213081 Date26 Oct 2021DecidedStatusActive
United StatesGUDID listing Number08054890480086 UDI-DI Date11 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213081 decided 26 Oct 2021 Active
  • FDA GUDID UDI-DI 08054890480086 listed 11 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08054890480086
  2. Cleared FDA 510(k) K213081

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Clisis Systems
Generic name
Portable general-purpose fluoroscopic x-ray system, analogue
Model / reference
WS
Primary DI / UDI-DI
08054890480086
510(k) Number
FDA product code
IZL
GMDN term
Portable general-purpose fluoroscopic x-ray system, analogue
Device class
Class II
Regulation number
892.1720
GUDID distribution status
In Commercial Distribution

Related devices

Category: Portable general-purpose fluoroscopic x-ray system, analogue

Cleared under the same submission (K213081)

and 6 more cleared under K213081

Similar devices

Other devices filed under FDA product code IZL (System, X-Ray, Mobile).

Other devices from General Medical Merate SpA

See all devices from General Medical Merate SpA →

Properties

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