Identity
- Trade Name
- ImagenSPECT FDA UDI
- Generic Name
- SPECT system application software FDA UDI
- Device Name
- The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy. FDA UDI
- Model / Reference
- 2.0 FDA UDI
- Description
- The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00862611000301 FDA UDI
- 510(k) Number
- K152503 FDA UDI
- FDA Product Code
- LLZ FDA UDIKPS FDA UDI
- GMDN Term
- SPECT system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI892.1200 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiology DICOM image processing application softwareSPECT system application software
ImagenSPECT by Cardiovascular Imaging Technologies L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as SPECT system application software.
- UltraSPECT — ULTRASPECT USA, LLC · Class II
- UltraSPECT — ULTRASPECT USA, 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
Cleared under the same submission
K152503 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cardiovascular Imaging Technologies L.l.c.
Sources (1)
- FDA UDI 7d57ac9a-4d33-42da-ba8a-af52d629d5e6 35 fields · synced May 30, 2026