Is this your brand? Sign in to claim ownership.
Sign in to claim this brandIBEX MEDICAL ANALYTICS LTD
US
Last updated May 24, 2026
What IBEX MEDICAL ANALYTICS LTD makes
IBEX MEDICAL ANALYTICS LTD develops histology/cytology/microbiology image-analysis interpretive software IVD devices, including Ibex Prostate Detect and Galen Second Read.
The company's devices are classified as Class II and are listed in the FDA 510(k) and FDA UDI registries. IBEX MEDICAL ANALYTICS LTD is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does IBEX MEDICAL ANALYTICS LTD manufacture?
IBEX MEDICAL ANALYTICS LTD develops histology/cytology/microbiology image-analysis interpretive software IVD devices, including Ibex Prostate Detect and Galen Second Read. These devices are designed to assist in the analysis of medical images in pathology laboratories.
Where is IBEX MEDICAL ANALYTICS LTD based?
IBEX MEDICAL ANALYTICS LTD is based in the United States. The company operates from its headquarters in the US, where it develops and markets its medical imaging analysis software products.
Which regulatory registries list IBEX MEDICAL ANALYTICS LTD's devices?
IBEX MEDICAL ANALYTICS LTD's devices are listed in the FDA 510(k) and FDA UDI registries. These listings indicate that the devices have been submitted to the FDA for review and are assigned unique device identifiers for tracking purposes.
How are IBEX MEDICAL ANALYTICS LTD's devices classified?
IBEX MEDICAL ANALYTICS LTD's devices are classified as Class II medical devices. This classification indicates moderate-risk devices that require special controls to ensure their safety and effectiveness, but generally do not require pre-market approval from the FDA.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 531906350
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ibex Prostate Detect | 3.1-US | FDA UDI | Class II | Active |
| Galen™ Second Read™ | K241232 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.