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Symbia Pro.specta X3

FDA UDI

Class II (US FDA UDI)

by Siemens Medical Solutions Usa, Inc.

Identity

Trade Name
Symbia Pro.specta X3 FDA UDI
Generic Name
SPECT/CT system FDA UDI
Model / Reference
11364752 FDA UDI

Identifiers

Primary DI / UDI-DI
04056869264752 FDA UDI
510(k) Number
K210557 FDA UDI
K212604 FDA UDI
K231102 FDA UDI
K243186 FDA UDI
FDA Product Code
KPS FDA UDI
GMDN Term
SPECT/CT system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1200 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: SPECT/CT system

Symbia Pro.specta X3 by Siemens Medical Solutions Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as SPECT/CT system.

Cleared under the same submission

K210557 also covers:

K212604 also covers:

K231102 also covers:

K243186 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Medical Solutions Usa, Inc.

Sources (1)

  • FDA UDI 1f1616e5-3fc0-41f2-a81e-29e6fc4b1909 34 fields · synced Jun 8, 2026