Data / Medical devices / United States / Heartlung Corporation
Heartlung Corporation: FDA-registered device maker in Houston, TX, United States, 2 510(k) clearances
Heartlung Corporation is registered with the FDA (registration 3039211310) in Houston, TX, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 10, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039211310
- Address
- 2450 Holcombe Blvd, Houston, TX, United States, 77021
- Owner or operator
- HeartLung Corporation (10093760)
- Roles
- Manufacturer
- First device listed
- July 3, 2025
- Registered through
- 2026
- Brand names listed
- AI-CVD, AutoBMD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Densitometer, Bone | KGI | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 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 |
|---|---|---|---|---|---|---|
| October 10, 2024 | K240786 | AutoChamber | QIH | Substantially Equivalent | HeartLung Corporation | accessdata.fda.gov |
| July 29, 2022 | K213760 | ABMD Software | KGI | Substantially Equivalent | HeartLung Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Densitometer, Bone
- All makers of System, X-Ray, Tomography, Computed
- All makers of Automated Radiological Image Processing Software
Updated October 10, 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.