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syngo.Interventional

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare

Identity

Trade Name
syngo.Interventional FDA UDI
Generic Name
Basic diagnostic x-ray system application software FDA UDI
Device Name
syngo.Interventional VB10;Medical Device syngo.Interventional VB10 is covered by NFJ to K143319 "Syngo X-Workplace SW VD10" FDA UDI
Model / Reference
10849138 FDA UDI
Description
syngo.Interventional VB10;Medical Device syngo.Interventional VB10 is covered by NFJ to K143319 "Syngo X-Workplace SW VD10" FDA UDI

Identifiers

Primary DI / UDI-DI
04056869020518 FDA UDI
510(k) Number
K143319 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Basic diagnostic x-ray system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Basic diagnostic x-ray system application software

syngo.Interventional by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic diagnostic x-ray system application software.

Cleared under the same submission

K143319 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare

Sources (1)

  • FDA UDI 0b6fe232-7221-4958-a7a7-66bb2bb9f5ad 35 fields · synced May 31, 2026