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syngo.Interventional 11327747

by Siemens Healthcare GmbH

syngo.Interventional 11327747 is a Class II device made by Siemens Healthcare GmbH, cleared under FDA 510(k) K170747 on 9 Jun 2017 and listed in FDA GUDID since 1 Aug 2018 (UDI-DI 04056869164311), active as of 12 Nov 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 12 Nov 2026

Documents

510(k) K170747

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04056869164311 UDI-DI Date1 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170747 Date9 Jun 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170747 decided 9 Jun 2017 Active
  • FDA GUDID UDI-DI 04056869164311 listed 1 Aug 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170747
  2. Listed FDA GUDID 04056869164311

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
syngo.Interventional
Generic name
Basic x-ray clinical assessment support software
Model / reference
11327747
Primary DI / UDI-DI
04056869164311
510(k) Number
FDA product code
LLZ
GMDN term
Basic x-ray clinical assessment support software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic diagnostic x-ray system application software

Cleared under the same submission (K170747)

Other devices from Siemens Healthcare GmbH

See all devices from Siemens Healthcare GmbH →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)