Data / Medical devices / United States / Kub Technologies, Inc.
Kub Technologies, Inc.: FDA-registered device maker in Stratford, CT, United States, 10 510(k) clearances
Kub Technologies, Inc. is registered with the FDA (registration 3006051164) in Stratford, CT, United States. It lists 6 device types. The FDA files 10 510(k) clearances under its listings, the newest dated September 20, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006051164
- Address
- 111 Research DR, Stratford, CT, United States, 06615
- Owner or operator
- Kub Technologies (10028645)
- Roles
- Manufacturer
- First device listed
- February 20, 2009
- Registered through
- 2027
- Brand names listed
- DIGIVIEW 395, Digiview 250, KUB 250, KUBBIE, KUBTEC GammaPRO, MOZART, MOZART (XPERT42), MOZART SUPRA (XPERT84) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cabinet, X-Ray System | MWP | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Manufacturer | accessdata.fda.gov |
| Probe, Uptake, Nuclear | IZD | 1 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 20, 2021 | K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | MWP | Substantially Equivalent | Kub Technologies, Inc. | accessdata.fda.gov |
| August 31, 2021 | K210957 | Kubec Xpert 80 Radiography System | MWP | Substantially Equivalent | Kub Technologies, Inc. | accessdata.fda.gov |
| August 31, 2021 | K210956 | Kubtec Mozart (XPERT42) | MWP | Substantially Equivalent | Kub Technologies, Inc. | accessdata.fda.gov |
| June 12, 2020 | K200756 | Kubtec Mozart Supra | MWP | Substantially Equivalent | Kub Technologies, Inc. | accessdata.fda.gov |
| June 20, 2019 | K183624 | Kubtec Mozart (Xpert42) | MWP | Substantially Equivalent | Kub Technologies, Inc. | accessdata.fda.gov |
| June 23, 2015 | K151221 | Kubtec DIGIVIEW 395 | MQB | Substantially Equivalent | Kub Technologies, Inc. | accessdata.fda.gov |
| October 29, 2014 | K141539 | KUBTEC X250 | IZL | Substantially Equivalent | Kub Technologies, Inc. | accessdata.fda.gov |
| October 20, 2011 | K103348 | DIGIVIEW 250 | MQB | Substantially Equivalent | Kub Technologies, Inc. | accessdata.fda.gov |
| January 8, 2009 | K083510 | KUBTEC XPERT 20 | KPR | Substantially Equivalent | Kub Technologies, Inc. | accessdata.fda.gov |
| June 20, 2007 | K071233 | XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM | MWP | Substantially Equivalent | Kub Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cabinet, X-Ray System
- All makers of System, X-Ray, Mobile
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Stationary
- All makers of Probe, Uptake, Nuclear
- All makers of Container, Specimen, Sterile
Updated September 20, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.