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syngo.Breast Care

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare

Identity

Trade Name
syngo.Breast Care FDA UDI
Generic Name
Diagnostic x-ray digital imaging system workstation application software FDA UDI
Device Name
Mammo Accessory FDA UDI
Model / Reference
10590800 FDA UDI
Description
Mammo Accessory FDA UDI

Identifiers

Primary DI / UDI-DI
04056869006871 FDA UDI
510(k) Number
K123420 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Diagnostic x-ray digital imaging system workstation 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Diagnostic x-ray digital imaging system workstation application software

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

Similar devices

Also classified as Diagnostic x-ray digital imaging system workstation application software.

Cleared under the same submission

K123420 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 83aa67c7-3b2f-4a59-bb35-d7e57b6d44eb 35 fields · synced May 30, 2026