Identifiers
- 510(k) Number
- K201316 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bladder Scanner is a medical device used for measuring bladder volume. It is designed to provide accurate and non-invasive assessment of urine volume in the bladder.
The device is supplied by SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD. and has received FDA 510K clearance. It is available in multiple models including M3, M3-HD, M4, and M4-HD.
Frequently asked questions
What is the purpose of the Bladder Scanner?
The Bladder Scanner is a medical device designed for non-invasive measurement of bladder volume. It provides accurate assessment of urine volume in the bladder, helping clinicians make informed decisions about patient care.
What models of the Bladder Scanner are available?
The Bladder Scanner is available in four models: M3, M3-HD, M4, and M4-HD. Each model offers different features and capabilities to meet various clinical needs for bladder volume assessment.
Is the Bladder Scanner sterile and single-use?
The device is not described as single-use in the provided information. Sterility details are not specified in the device data, so clinicians should refer to the manufacturer's instructions for proper handling and disinfection procedures between uses.
What regulatory approvals does the Bladder Scanner have?
The Bladder Scanner has received FDA 510K clearance with the K-number K201316. It was filed under the product code IYO and reviewed by the Radiology Advisory Committee, with a decision of 'Substantially Equivalent' in 2021.
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: Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) (K201316) — FDA 510 (k ..., PEAKSONIC, Bladder Scanner (Model: M3, M3-HD, M4, ... (K201316) - FDA 510 (k), PEAKSONIC
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201316 | Class II | Active |
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Manufacturer
- Manufacturer
- Suzhou Peaksonic Medical Technology Co., Ltd.
Sources (1)
- FDA 510(k) K201316 24 fields · synced Sep 22, 2026