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Sign in to claim this brandKUB TECHNOLOGIES INC
United States·US-MF-000026338
Last updated June 8, 2026
About
Making a life-changing difference for breast cancer patients by redefining specimen radiography and gamma detection across the operating room, pathology lab and biopsy suite.
From the manufacturer's own website. Source
What KUB TECHNOLOGIES INC makes
KUB Technologies Inc manufactures gamma detection systems and specimen radiography devices designed for use in operating rooms, pathology labs, and biopsy suites. Their product line includes handheld gamma probes (e.g., XPERT series) and gamma imaging systems (e.g., GammaPro variants) for intraoperative and post-operative localization of sentinel lymph nodes and other radiolabeled tissues. The devices also support imaging of excised specimens to verify complete removal of targeted tissue.
The company’s devices are classified under EU regulations as Class I and Class IIa, with relevant products registered in the EU’s eudamed database. While primarily focused on the European market through eudamed listings, the portfolio is also aligned with FDA requirements for Class I and Class IIa devices in the US. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does KUB Technologies Inc manufacture?
KUB Technologies Inc specializes in gamma detection systems and specimen radiography devices. These include handheld gamma probes (such as the XPERT20, XPERT40, XPERT42, and XPERT80L) and gamma imaging systems (like the GammaPro Standard, GammaPro Slim Angled, GammaPro Slim Laparoscopic, and GammaPro Slim Straight). The devices are designed for intraoperative and post-operative use in operating rooms, pathology labs, and biopsy suites, primarily for localizing radiolabeled tissues like sentinel lymph nodes and imaging excised specimens.
Where is KUB Technologies Inc based?
KUB Technologies Inc is based in the United States. The company’s headquarters and operations are located within the country, though its devices are marketed and used globally, including in regions regulated by the EU and FDA.
Which regulatory registries list KUB Technologies Inc’s devices?
KUB Technologies Inc’s devices are listed in the EU’s eudamed database, which serves as the official registry for medical devices under EU regulations. This registry ensures transparency and traceability of devices classified as Class I and Class IIa, which aligns with the classification of their gamma detection and specimen radiography products.
How are KUB Technologies Inc’s devices classified under EU regulations?
Under EU regulations, KUB Technologies Inc’s devices are classified as either Class I or Class IIa. This classification is determined by factors such as the device’s intended use, risk level, and potential impact on patient safety. For example, handheld gamma probes like the XPERT series may fall under Class I due to their lower risk profile, while gamma imaging systems like the GammaPro variants—due to their more complex functionality and higher risk—are classified as Class IIa.
Are KUB Technologies Inc’s devices designed for specific clinical settings?
Yes, KUB Technologies Inc’s devices are specifically designed for use in multiple clinical settings, including operating rooms, pathology labs, and biopsy suites. The XPERT series handheld probes are often used intraoperatively to locate radiolabeled tissues like sentinel lymph nodes during surgery, while the GammaPro imaging systems are tailored for post-operative specimen radiography to confirm complete removal of targeted tissue. This versatility ensures compatibility with workflows across different stages of patient care.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 111, Research Drive, Stratford, United States
- Website
- www.kubtec.com
- linkedin.com/company/kubtec
- facebook.com/kubtec
- [email protected]
- Phone
- +1 2033648544
- PRRC Contact
- Chester Lowe PhD
- EUDAMED SRN
- US-MF-000026338
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Xpert 40 Specimen Radiography System | K071233 | FDA 510(k) | Class II | Active |
| Kubtec Xpert 20 | K083510 | FDA 510(k) | Class II | Active |
| Kubec Xpert 80 Radiography System | K210957 | FDA 510(k) | Class II | Active |
| Kubtec Mozart Supra | K200756 | FDA 510(k) | Class II | Active |
| Kubtec X250 | K141539 | FDA 510(k) | Class II | Active |
| Kubtec Mozart (Xpert42) | K183624 | FDA 510(k) | Class II | Active |
| Kubtec Mozart Supra (XPERT 84) Radiography System | K210955 | FDA 510(k) | Class II | Active |
| Digiview 250 | K103348 | FDA 510(k) | Class II | Active |
| Kubtec Mozart (XPERT42) | K210956 | FDA 510(k) | Class II | Active |
| Kubtec DIGIVIEW 395 | K151221 | FDA 510(k) | Class II | Active |
| Xpert20 | XPERT20 | EUDAMED | Class I | Active |
| Xpert84 | XPERT84 | EUDAMED | Class I | Active |
| GammaPro Standard | K0019C01 | EUDAMED | Class IIa | Active |
| Xpert40 | XPERT40 | EUDAMED | Class I | Active |
| GammaPro Slim Angled | K0021C01 | EUDAMED | Class IIa | Active |
| Xpert80l | XPERT80L | EUDAMED | Class I | Active |
| GammaPro Slim Laparoscopic | K0020C01 | EUDAMED | Class IIa | Active |
| GammaPro Slim Straight | K0018C01 | EUDAMED | Class IIa | Active |
| Xpert42 | XPERT42 | EUDAMED | Class I | Active |
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