Identity
- Trade Name
- aPROMISE FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- aPROMISE is a softwareonly medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensityweighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results. FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- aPROMISE is a softwareonly medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensityweighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results. FDA UDI
Identifiers
- Catalog Number
- 501 FDA UDI
- Primary DI / UDI-DI
- 07350002335017 FDA UDI
- 510(k) Number
- K211655 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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Convenience Kit
No
FDA UDI
Combination Product
No
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HCT/P
No
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Premarket Exempt
No
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Lot / Batch Number
Yes
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Serial Number
No
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Expiration Date
No
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Manufacturing Date
No
FDA UDI
aPROMISE by Exini Diagnostics AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Exini Diagnostics AB
Sources (1)
- FDA UDI 7c482232-a1b4-4055-98e3-594b8132c0d6 37 fields · synced Jun 8, 2026