Data / Medical devices / United States / Compass Innovations, Inc
Compass Innovations, Inc: FDA-registered device maker in Santa Clara, CA, United States, 10 510(k) clearances
Compass Innovations, Inc is registered with the FDA (registration 3014634069) in Santa Clara, CA, United States. It lists 2 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 30, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014634069
- Address
- 990 Richard Ave Ste 110, Santa Clara, CA, United States, 95050
- Owner or operator
- COMPASS INNOVATIONS, INC (10061239)
- Roles
- Manufacturer, Remanufacturer, Repackager or relabeler
- First device listed
- October 2, 2019
- Registered through
- 2026
- Brand names listed
- CareView 1500C X-Ray Flat Panel Detectors, CareView 1500Cw X-Ray Flat Panel Detectors, CareView 1500Cwe, CareView 1500P, CareView 1800Cw X-Ray Flat Panel Detector, CareView 1800Cwe, CareView 1800L, CareView 1800Le and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Manufacturer, Remanufacturer | 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 |
|---|---|---|---|---|---|---|
| December 30, 2022 | K223687 | X-ray Flat Panel Detectors (EverestView 4343X) | MQB | Substantially Equivalent | Careray Digital Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 7, 2020 | K201932 | X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| December 13, 2019 | K193173 | CareView 1800Le | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| September 26, 2017 | K172581 | CareView 1800Cw X-ray Flat Panel Detectors | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| December 1, 2016 | K163019 | CareView 750Cw/750C X-ray Flat Panel Detectors | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| September 1, 2016 | K162178 | CareView 1500P X-ray Flat Panel Detectors | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| December 24, 2015 | K153492 | CareView 1800L | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| November 10, 2015 | K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| September 8, 2015 | K141488 | CAREVIEW 1800R | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| August 4, 2015 | K150929 | CareView 1500Cw X-ray Flat Panel Detectors | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
Updated December 30, 2022. 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.