Heartvista, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Heartvista, Inc.” (first 2014, latest 2021), across 1 product code in 1 review panel. Median 510(k) review time under this name: 185 days. Since 2017 the median was 185 days, against 101 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 2 | 128 |
| 2015 | 0 | — |
| 2016 | 1 | 185 |
| 2017 | 1 | 185 |
| 2018 | 0 | — |
| 2019 | 1 | 329 |
| 2020 | 0 | — |
| 2021 | 1 | 81 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Heartvista, Inc. took a median 185 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 6 | 6 |
Review panels
- Radiology (6)
Most recent Heartvista, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212233 | RTHawk, HeartVista Cardiac Package | LNH | 2021-10-05 | 81 |
| K183274 | RTHawk, HeartVista Cardiac Package | LNH | 2019-10-18 | 329 |
| K170090 | RTHawk, HeartVista Cardiac Package | LNH | 2017-07-14 | 185 |
| K153740 | RTHawk, HeartVista Cardiac Package | LNH | 2016-06-30 | 185 |
| K142997 | RTHawk, HeartVista Workstation with RTHawk | LNH | 2014-12-17 | 68 |
| K133848 | RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK | LNH | 2014-06-25 | 189 |
Recalls
openFDA lists no recalls under a recalling firm named Heartvista, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Heartvista, Inc. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Heartvista, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Heartvista, Inc.” (first 2014, latest 2021), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Heartvista, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heartvista, Inc. is 185 days. Since 2017: 185 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Heartvista, Inc.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 6).
Next steps
- See all 6 Heartvista, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Heartvista, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.