Data / Medical devices / United States / Exo Imaging, Inc.
Exo Imaging, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 5 510(k) clearances
Exo Imaging, Inc. is registered with the FDA (registration 3017487805) in Santa Clara, CA, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017487805
- Address
- 4201 Burton Drive, Santa Clara, CA, United States, 95054
- Owner or operator
- Exo Imaging (10085070)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 2, 2022
- Registered through
- 2026
- Brand names listed
- Exo Iris, Exo Works Enterprise/ Exo Works Connect
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 20, 2024 | K242359 | Strain AI (SAI001) | QIH | Substantially Equivalent | Exo, Inc. | accessdata.fda.gov |
| August 5, 2024 | K240953 | AI Platform 2.0 (AIP002) | QIH | Substantially Equivalent | Exo Imaging | accessdata.fda.gov |
| November 17, 2023 | K232501 | AI Platform (AIP001) | QIH | Substantially Equivalent | Exo, Inc. | accessdata.fda.gov |
| June 22, 2023 | K230497 | Bladder AI (AIBV01) | QIH | Substantially Equivalent | Exo, Inc. | accessdata.fda.gov |
| November 9, 2022 | K222198 | Exo Iris (El2001) | IYN | Substantially Equivalent | Exo Imaging, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Automated Radiological Image Processing Software
- All makers of System, Digital Image Communications, Radiological
Updated November 20, 2024. 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.