Flex Focus 1202 Ultrasound Scanner
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132677 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Flex Focus 1202 is a portable ultrasound scanner designed for diagnostic imaging of soft tissues, organs, and vascular structures. It employs high-frequency sound waves to generate real-time visual images, aiding in the assessment of anatomical and pathological conditions. This device is classified as a diagnostic ultrasound system, suitable for professional medical use in various clinical settings. Its modular design supports flexibility in imaging applications, including musculoskeletal, abdominal, and vascular studies.
The Flex Focus 1202 is intended for single-use or reusable configurations, depending on the probe and accessories attached, though sterility requirements must be adhered to per clinical protocol. It is supplied as a standalone system with optional add-ons for extended functionality and is not MRI-safe. The device is regulated under FDA 510(k) clearance (K132677) and is intended for use in professional medical environments by trained operators. Storage conditions should follow manufacturer guidelines to maintain performance and safety.
Frequently asked questions
What clinical applications is the Flex Focus 1202 ultrasound scanner designed for?
The Flex Focus 1202 is specifically designed for diagnostic imaging of soft tissues, organs, and vascular structures. Its modular design makes it versatile for musculoskeletal assessments, abdominal studies, and vascular evaluations, supporting a wide range of professional medical applications in clinical environments.
How is the Flex Focus 1202 supplied, and can it be reused?
The Flex Focus 1202 is supplied as a standalone portable ultrasound system, with optional add-ons available for expanded functionality. Reusability depends on the attached probes and accessories—some configurations allow reuse, while others are intended for single-use. Sterility must always be maintained according to clinical protocols to ensure patient safety.
Is the Flex Focus 1202 MRI-safe, and what storage guidelines should be followed?
The Flex Focus 1202 is explicitly not MRI-safe, meaning it should never be used or stored in an MRI environment. To maintain performance and safety, storage should adhere to the manufacturer’s guidelines, which likely include protecting the device from extreme temperatures, moisture, and physical damage.
What distinguishes the Flex Focus 1202 from other portable ultrasound scanners?
The Flex Focus 1202 stands out due to its modular design, enabling flexibility across musculoskeletal, abdominal, and vascular imaging. Its portable form factor and FDA 510(k) clearance (K132677) also differentiate it, ensuring regulatory compliance for professional medical use while offering adaptability for various clinical workflows.
What regulatory pathway does the Flex Focus 1202 follow, and who is the applicant?
The Flex Focus 1202 follows the FDA 510(k) clearance pathway, classified under the Radiology advisory committee (RA) and determined as Substantially Equivalent (SESE). The applicant for this clearance is B-K Medical Aps, based in Herlev, Denmark, with the submission received on August 28, 2013, and cleared on January 7, 2014.
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: Ultrasound - Wikipedia, BK MEDICAL FLEX FOCUS 1202 USER MANUAL Pdf Download, BK Medical Flex Focus 1202 Advanced User's Manual, BK Ultrasound Flex Focus 1202 User Manual | Manualzz, Ultrasound: Purpose, Procedure, and Preparation - Healthline
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132677 | Class II | Active |
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Manufacturer
- Manufacturer
- B-K Medical Aps
Sources (1)
- FDA 510(k) K132677 24 fields · synced Oct 1, 2026