Sensus Healthcare, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Sensus Healthcare, Inc.” (first 2013, latest 2019), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 141 days. Since 2017 the median was 145 days, against 122 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 |
|---|---|---|
| 2013 | 2 | 114 |
| 2014 | 0 | — |
| 2015 | 1 | 280 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 141 |
| 2019 | 3 | 149 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 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 Sensus Healthcare, Inc. took a median 145 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAD | System, Therapeutic, X-Ray | 6 | 6 |
| MUJ | System, Planning, Radiation Therapy Treatment | 1 | 1 |
Review panels
- Radiology (7)
Most recent Sensus Healthcare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190255 | Sensus Healthcare TVM Balloon Applicator | JAD | 2019-02-21 | 14 |
| K182665 | Sensus TPS Workstation | MUJ | 2019-02-21 | 149 |
| K182641 | Sensus IORT System | JAD | 2019-02-21 | 150 |
| K173425 | SRT-100+ | JAD | 2018-03-23 | 141 |
| K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities | JAD | 2015-10-16 | 280 |
| K131582 | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM | JAD | 2013-08-28 | 89 |
| K123985 | SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 | JAD | 2013-05-14 | 139 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2023-02-10.
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.
SEC filings
Sensus Healthcare, Inc. (SRTS): EDGAR filings, CIK 1494891. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sensus Healthcare, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Sensus Healthcare, Inc.” (first 2013, latest 2019), across 2 product codes 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 Sensus Healthcare, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sensus Healthcare, Inc. is 141 days. Since 2017: 145 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sensus Healthcare, Inc.?
The most frequent FDA product codes under this applicant name are JAD (System, Therapeutic, X-Ray, 6); MUJ (System, Planning, Radiation Therapy Treatment, 1).
Next steps
- See all 7 Sensus Healthcare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAD, Sensus Healthcare, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.