Biovision Cardiac Strobe
510(k) K811341
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811341 | Date16 Jul 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Biovision Cardiac Strobe is a cardiac imaging device classified under the nomenclature for electrocardiographic (ECG) machines. It is designed to facilitate precise cardiac rhythm analysis and visualization of cardiac electrical activity, aiding in the assessment of cardiac function and pathology. This device supports diagnostic evaluations in cardiovascular settings by providing real-time cardiac monitoring and strobe illumination for enhanced visualization of cardiac structures during imaging procedures.
This device is supplied as a reusable medical instrument and is intended for use in clinical environments where cardiac diagnostics are performed. It has received FDA 510(k) clearance under the product code DPS, indicating regulatory approval for marketing in the United States. The Biovision Cardiac Strobe is not described as MRI-safe or single-use in the available specifications, and no additional details regarding sterility or storage conditions are provided. Its original clearance date is 1981, and it remains authorized under traditional 510(k) review.
Questions
AI-generated answers, 1 Oct 2026
What is the Biovision Cardiac Strobe used for?
The Biovision Cardiac Strobe is designed to assist in cardiac diagnostics by providing real-time cardiac monitoring and strobe illumination. This enhances visualization of cardiac structures during imaging procedures, aiding clinicians in assessing cardiac function and identifying potential pathologies. Its strobe feature helps synchronize imaging with cardiac electrical activity, improving diagnostic accuracy in cardiovascular evaluations.
Is the Biovision Cardiac Strobe a single-use or reusable device?
The Biovision Cardiac Strobe is supplied as a reusable medical instrument. This classification aligns with its intended use in clinical environments where multiple patients may require cardiac imaging over time, ensuring cost-effectiveness and reduced waste.
What regulatory approval does the Biovision Cardiac Strobe hold?
The Biovision Cardiac Strobe has received FDA 510(k) clearance under the product code DPS, indicating it is authorized for marketing in the United States. The clearance was granted under a traditional 510(k) review process, with the device classified as substantially equivalent to a predicate device. The original clearance date was July 16, 1981.
Does the Biovision Cardiac Strobe come with any specific sterility or storage instructions?
The provided specifications do not explicitly detail sterility requirements or storage conditions for the Biovision Cardiac Strobe. As a reusable device, proper cleaning and maintenance protocols should be followed to ensure hygiene and functionality. Clinicians should consult manufacturer guidelines for specific recommendations on cleaning, disinfection, and storage to prevent contamination and maintain device performance.
What advisory committee reviewed the Biovision Cardiac Strobe?
The Biovision Cardiac Strobe was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee during its 510(k) clearance process. This committee provides expert guidance on cardiovascular devices, ensuring that submissions meet safety and effectiveness standards for use in cardiac diagnostics and treatment.