Novarad Corporation: FDA clearances and approvals
Novarad Corporation has 7 FDA 510(k) clearances (first 2006, latest 2022), across 2 product codes in 2 review panels. Median 510(k) review time: 128 days. Since 2017 its median was 128 days, against 113 days for all cleared 510(k)s in the same product codes. openFDA lists 4 product recalls by a recalling firm named Novarad Corporation.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 413 |
| 2015 | 0 | — |
| 2016 | 1 | 247 |
| 2017 | 1 | 45 |
| 2018 | 1 | 407 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 128 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Novarad Corporation's cleared 510(k)s took a median 128 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 6 | 6 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Radiology (6)
- Orthopedic (1)
Most recent Novarad Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220146 | VisAR | OLO | 2022-05-27 | 128 |
| K172418 | OpenSight | LLZ | 2018-09-21 | 407 |
| K171754 | NovaPACS | LLZ | 2017-07-28 | 45 |
| K160371 | NovaPACS | LLZ | 2016-10-14 | 247 |
| K132853 | NOVAPACS | LLZ | 2014-10-30 | 413 |
| K063153 | NOVAPACS | LLZ | 2006-12-07 | 52 |
| K061920 | NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER | LLZ | 2006-08-21 | 46 |
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2019-09-10.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Novarad Corporation have?
Novarad Corporation has 7 FDA 510(k) clearances (first 2006, latest 2022), across 2 product codes in 2 review panels.
How long does FDA take to clear Novarad Corporation's 510(k)s?
The median time from FDA receipt to decision across Novarad Corporation's cleared 510(k)s is 128 days. Since 2017: 128 days, versus 113 days for all cleared 510(k)s in the same product codes.
What devices does Novarad Corporation make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 6); OLO (Orthopedic Stereotaxic Instrument, 1).
Has Novarad Corporation had device recalls?
openFDA lists 4 product recalls in 4 recall events by a recalling firm whose name matches Novarad Corporation; the most recent began 2019-09-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Novarad Corporation clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Novarad Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.