syngo Application Software 10849231

by Siemens Healthcare GmbH

syngo Application Software 10849231 is a Class II device made by Siemens Healthcare GmbH, cleared under FDA 510(k) K173611 on 16 Mar 2018 (2 earlier submissions) and listed in FDA GUDID since 10 Apr 2017 (UDI-DI 04056869050874), 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

+2 more

Trust

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK173611	Date16 Mar 2018Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK170747	Date9 Jun 2017Decided	StatusActive
United States	GUDID listing	Number04056869050874 UDI-DI	Date10 Apr 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK163285	Date14 Feb 2017Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04056869050874
FDA 510(k) database 510(k) number K173611
FDA 510(k) database 510(k) number K170747
FDA 510(k) database 510(k) number K163285

Across registries

2 registries list this device

FDA 510(k) K173611 decided 16 Mar 2018 Active· +2 more in the status table
FDA GUDID UDI-DI 04056869050874 listed 10 Apr 2017 Listed

Timeline

4 dated events

14 Feb 2017 Cleared FDA 510(k) K163285
10 Apr 2017 Listed FDA GUDID 04056869050874
9 Jun 2017 Cleared FDA 510(k) K170747
16 Mar 2018 Cleared FDA 510(k) K173611

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: syngo Application Software
Generic name: Basic x-ray clinical assessment support software
Model / reference: 10849231

Primary DI / UDI-DI: 04056869050874
510(k) Number: K163285
K170747
K173611
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

Similar devices in this category

Other devices filed under Basic diagnostic x-ray system application software.

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)