syngo.MI Cardiology
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- syngo.MI Cardiology EUDAMEDFDA UDI
- Generic Name
- SPECT system application software FDA UDI
- Device Name
- Image Processing Software_10_IIa_HES EUDAMED
- Model / Reference
- 11431558 EUDAMEDFDA UDIImage Processing Software_10_IIa_HES EUDAMED11431528 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869950150 EUDAMEDFDA UDI04056869243368 FDA UDI
- Basic UDI-DI
- 0405686900137UX EUDAMED
- FDA Product Code
- LLZ FDA UDIQIH FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- SPECT system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: SPECT system application softwarePET system application software
syngo.MI Cardiology by Siemens Medical Solutions Usa, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as PET system application software.
- mfiVerse — Multifunctional Imaging, LLC · Class II
- syngo.PET&CT Oncology — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- syngo MBF — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- syngo.MI Neurolog — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- syngo.MI General — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- syngo Scenium SPECT — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- syngo.PET&CT Oncology — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- SW-Key: NMG_SCENIUM_ADV VIA — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Medical Solutions Usa, Inc.
Sources (3)
- FDA UDI 96f8d277-f71c-473c-9b47-d4e07bd37bf0 34 fields · synced Jul 21, 2026
- FDA UDI 63e4fddb-e90f-43ef-97e7-d71bdcd4dfbb 34 fields · synced May 29, 2026
- EUDAMED 560408c3-552a-44ef-8095-a8b05c4f70c3 61 fields · synced Jul 21, 2026