Data / Medical devices / United States / ASTUTE IMAGING Inc
ASTUTE IMAGING Inc: FDA-registered device maker in Hanover, NH, United States, 1 510(k) clearance
ASTUTE IMAGING Inc is registered with the FDA (registration 3021625328) in Hanover, NH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 23, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021625328
- Address
- 53 South Main Street Suite 313, Hanover, NH, United States, 03755
- Owner or operator
- Astute Imaging LLC (10084326)
- Roles
- Manufacturer
- First device listed
- February 10, 2022
- Registered through
- 2026
- Brand names listed
- Preview® Treatment Planning Software, cvi42 Vascular CT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| April 23, 2004 | K040852 | PREVIEW TREATMENT PLANNING SOFTWARE | LLZ | Substantially Equivalent | Medical Media Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 23, 2004. 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.