Data / Medical devices / United States / Insight Medical Systems, Inc
Insight Medical Systems, Inc: FDA-registered device maker in Austin, TX, United States, 1 510(k) clearance
Insight Medical Systems, Inc is registered with the FDA (registration 3019878658) in Austin, TX, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 13, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3019878658
- Address
- 9801 Metric Boulevard, Austin, TX, United States, 78758
- Owner or operator
- Kico Knee Innovation Company (10054916)
- Roles
- Specification developer
- First device listed
- August 3, 2025
- Registered through
- 2027
- Brand names listed
- ARVIS Surgical Navigation System, ARVIS® Shoulder
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Specification developer | accessdata.fda.gov |
| Orthopedic Augmented Reality | SBF | 2 | Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| January 13, 2025 | K243950 | ARVIS® Shoulder | SBF | Substantially Equivalent | Kico Knee Innovation Company Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Augmented Reality
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
Updated January 13, 2025. 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.