Data / Medical devices / United States / Empyrean Medical Systems, Inc.
Empyrean Medical Systems, Inc.: FDA-registered device maker in Boca Raton, FL, United States, 3 510(k) clearances
Empyrean Medical Systems, Inc. is registered with the FDA (registration 3023344262) in Boca Raton, FL, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 21, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023344262
- Address
- 3010 N Military Trail #220, Boca Raton, FL, United States, 33431
- Owner or operator
- Empyrean Medical Systems, Inc. (10085591)
- Roles
- Specification developer
- First device listed
- July 7, 2022
- Registered through
- 2026
- Brand names listed
- Morpheus, Morpheus TPS Workstation, TVM Balloon Applicator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Specification developer | accessdata.fda.gov |
| System, Therapeutic, X-Ray | JAD | 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 |
|---|---|---|---|---|---|---|
| February 21, 2019 | K190255 | Sensus Healthcare TVM Balloon Applicator | JAD | Substantially Equivalent | Sensus Healthcare, Inc. | accessdata.fda.gov |
| February 21, 2019 | K182665 | Sensus TPS Workstation | MUJ | Substantially Equivalent | Sensus Healthcare, Inc. | accessdata.fda.gov |
| February 21, 2019 | K182641 | Sensus IORT System | JAD | Substantially Equivalent | Sensus Healthcare, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 21, 2019. 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.