Identity
- Trade Name
- Imbio RV/LV FDA UDI
- Generic Name
- X-ray image interpretive software FDA UDI
- Device Name
- The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal. FDA UDI
- Model / Reference
- 2.1 FDA UDI
- Description
- The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850894007636 FDA UDI
- 510(k) Number
- K203256 FDA UDI
- FDA Product Code
- QIH FDA UDI
- GMDN Term
- X-ray image interpretive 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: X-ray image interpretive software
Imbio RV/LV by Imbio, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K203256 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
- Imbio, LLC
Sources (1)
- FDA UDI a2642eb4-d9e7-4be9-9244-4a385c98ac38 34 fields · synced May 30, 2026