UBM Plus Model P45
by Paradigm Medical Industries, Inc.
510(k) K003141
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003141 | Date5 Dec 2000 | 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- Withdrawn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
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The UBM Plus Model P45 is a Class II ultrasound imaging system designed for diagnostic radiology applications. It employs ultrasound technology to generate real-time images of internal body structures, aiding in the assessment of organs, tissues, and potential abnormalities. This device is intended for use in clinical settings where detailed visualization of soft tissues and fluid-filled spaces is required. Its classification aligns with the FDA’s regulatory framework for radiology devices, ensuring compliance with safety and performance standards.
The UBM Plus Model P45 is supplied as a reusable medical device, intended for use in radiology departments within healthcare facilities. It holds an FDA 510(k) clearance under K-number K003141, granted in December 2000, and is classified under product code IYO. The device is not indicated for MRI environments, and its specifications do not specify sterility requirements beyond standard hospital reprocessing protocols. Storage and maintenance follow manufacturer guidelines to ensure optimal performance and longevity.
Other devices from Paradigm Medical Industries, Inc.
Questions
AI-generated answers, 20 Sep 2026
Is the UBM Plus Model P45 designed for single-use or can it be reused in a clinical setting?
The UBM Plus Model P45 is explicitly supplied as a reusable medical device, intended for use in radiology departments within healthcare facilities. It follows standard hospital reprocessing protocols for maintenance and reuse, ensuring compliance with clinical hygiene standards.
What type of regulatory clearance does the UBM Plus Model P45 hold, and how was it determined?
The UBM Plus Model P45 holds an FDA 510(k) clearance under K-number K003141, granted in December 2000. The clearance was determined through a Special Review by the Radiology (RA) Advisory Committee, where the device was classified as Substantially Equivalent (SESE) to a predicate device, ensuring compliance with FDA safety and performance standards for radiology imaging systems.
Can this device be used in an MRI environment, or are there specific restrictions?
The UBM Plus Model P45 is not indicated for use in MRI environments. The manufacturer’s specifications explicitly exclude MRI compatibility, so it should only be used in non-MRI settings to avoid interference or safety risks.
How is the UBM Plus Model P45 stored and maintained to ensure optimal performance?
Storage and maintenance of the UBM Plus Model P45 follow manufacturer-provided guidelines to preserve functionality and longevity. Since it is reusable, proper reprocessing (cleaning, disinfection, and sterilization if required) must adhere to hospital protocols. The device requires routine calibration and technical support to maintain imaging accuracy and reliability.
What clinical applications is the UBM Plus Model P45 primarily intended for?
The UBM Plus Model P45 is designed for diagnostic radiology applications, specifically for generating real-time ultrasound images of soft tissues and fluid-filled spaces. It aids clinicians in assessing organs and identifying potential abnormalities, making it useful in general diagnostic imaging rather than specialized procedures.