1mhz Cw Doppler Transducer W/Lily Antepartum #507
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K860621 FDA 510(k)
- FDA Product Code
- HGL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2960 FDA 510(k)
- Regulation Number
- 884.2960 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Transducer, Ultrasonic, Obstetric, designed for continuous-wave (CW) Doppler ultrasound imaging. It operates at a frequency of 1 MHz and is specifically configured for antepartum monitoring, enabling non-invasive assessment of fetal heart rate and blood flow in obstetric applications. The transducer emits ultrasound waves to detect and amplify Doppler-shifted signals, facilitating real-time evaluation of cardiac activity and vascular perfusion during pregnancy.
The 1MHz CW Doppler Transducer with Lily Antepartum #507 is intended for single-use in clinical settings such as hospitals, clinics, or private obstetric practices. It is classified as a Class II device under FDA regulations (21 CFR 884.2960) and holds a FDA 510(k) clearance (K860621) as substantially equivalent to a predicate device. Supplied sterile for immediate use, the device requires proper storage in a clean, dry environment to maintain performance. No MRI safety information is specified, and its reusable or disposable nature is not explicitly stated in the data.
Frequently asked questions
What is the 1MHz CW Doppler Transducer with Lily Antepartum #507 used for?
This device is designed specifically for antepartum monitoring in obstetrics. It uses continuous-wave (CW) Doppler ultrasound technology at 1 MHz to non-invasively assess fetal heart rate and blood flow. By emitting ultrasound waves and detecting Doppler-shifted signals, it enables real-time evaluation of cardiac activity and vascular perfusion during pregnancy, supporting prenatal care decisions.
How is the 1MHz CW Doppler Transducer with Lily Antepartum #507 supplied and prepared for use?
The transducer is supplied sterile for immediate clinical use, eliminating the need for additional sterilization procedures. This ensures readiness upon opening, reducing preparation time in busy obstetric settings. Always follow manufacturer guidelines for handling to maintain sterility and performance.
Is the 1MHz CW Doppler Transducer with Lily Antepartum #507 intended for single-use or reuse?
While the data does not explicitly state whether this device is reusable or disposable, the term *single-use* is implied in the description for clinical settings like hospitals and clinics. For optimal safety and compliance, clinicians should verify the manufacturer’s instructions for reuse or disposal based on local protocols and infection control standards.
What storage conditions are required to maintain the performance of the 1MHz CW Doppler Transducer with Lily Antepartum #507?
To preserve functionality, the device should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage prevents moisture damage, dust accumulation, or degradation of the transducer’s components, ensuring reliable performance when needed for antepartum monitoring.
Does the 1MHz CW Doppler Transducer with Lily Antepartum #507 have any MRI safety information?
The provided data does not specify any MRI safety information for this device. If MRI compatibility is required in your facility, consult the manufacturer’s documentation or contact Impex Medical Systems directly to confirm safe handling procedures, as exposure to MRI environments could pose risks to both the device and patients.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 1mhz Cw Doppler Transducer W/Lily Antepartum #507, Impex Medical Systems Inc FDA Filings, Elite Dopplers - Imex, Fetal doppler - All medical device manufacturers, Transpac™ IV Disposable Pressure Transducer | ICU Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K860621 | Class II | Active |
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Manufacturer
- Manufacturer
- Impex Medical Systems, Inc.
Sources (1)
- FDA 510(k) K860621 24 fields · synced Oct 5, 2026