ALBUNEX Echocardiography Contrast Microspheres
PMA P900059
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP900059 | Date28 Aug 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Albunex(R) Echocardiography Contrast Microspheres
- Generic Name
- Contrast media, ultrasound
- PMA Number
- FDA Product Code
- MJS
- Device Class
- Class III
- Advisory Committee
- Radiology
- FDA Decision
- APPR Approved
- PMA Supplement
- S003 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
ALBUNEX Echocardiography Contrast Microspheres are an ultrasound contrast agent designed to enhance the visualization of cardiac structures during echocardiography. The device consists of microspheres that improve the reflection of ultrasound waves, allowing for better delineation of blood flow and myocardial borders.
Supplied as a sterile, single-use product for intravenous administration in clinical echocardiography settings. The device is regulated under FDA PMA (P900059) and is not indicated for MRI use. Storage and handling specifications are defined by the manufacturer’s approved labeling and authorization documentation.
Other devices from Molecular Biosystems, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary function of ALBUNEX Echocardiography Contrast Microspheres?
ALBUNEX Echocardiography Contrast Microspheres enhance ultrasound imaging by increasing the echogenicity of blood, which improves the visualization of cardiac chambers and blood flow during echocardiography procedures.
Is ALBUNEX Echocardiography Contrast Microspheres a single-use or reusable device?
ALBUNEX Echocardiography Contrast Microspheres are supplied as a sterile, single-use product intended for intravenous administration and are not designed for reuse.
What regulatory authorization does ALBUNEX Echocardiography Contrast Microspheres have?
ALBUNEX Echocardiography Contrast Microspheres received FDA Premarket Approval (PMA) under application number P900059, which was approved on August 28, 1995.