Diagnostic Ultrasound System Type 3535, Modified
by B&K Medical 510(k)
Active
510(k) K933056
Overview
The Diagnostic Ultrasound System Type 3535, Modified is a Class II medical imaging device classified under the nomenclature ‘System, Imaging, Pulsed Echo, Ultrasonic.’ It generates real-time ultrasound images for diagnostic evaluation, enabling visualization of internal body structures such as organs, tissues, and fluids through high-frequency sound waves. Designed for radiology applications, it facilitates non-invasive assessment of anatomical and pathological conditions.
This system is supplied as a reusable diagnostic tool, intended for use in radiology departments under sterile or controlled conditions. It operates under FDA clearance (510(k) K933056) and is categorized under product code IYO, with a regulatory classification of substantially equivalent (SESE). Storage and maintenance follow manufacturer guidelines to ensure proper functionality and compliance with imaging standards.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK933056 | Date24 Jun 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from B-K Medical A/S
Questions
Is this ultrasound system designed for single-use or can it be reused in a clinical setting?
This Diagnostic Ultrasound System Type 3535, Modified is explicitly described as a reusable diagnostic tool. It is intended for use in radiology departments under sterile or controlled conditions, meaning it must be properly cleaned, maintained, and stored according to the manufacturer’s guidelines to ensure functionality and compliance with imaging standards.
What types of internal structures can this ultrasound system visualize, and what is its primary clinical application?
The system generates real-time ultrasound images to visualize internal body structures such as organs, tissues, and fluids. Its primary clinical application is for non-invasive diagnostic evaluation of anatomical and pathological conditions, making it particularly useful in radiology for assessing internal structures without invasive procedures.
How is this device regulated, and what does the product code (IYO) indicate about its classification?
This device holds FDA clearance under 510(k) K933056, classified as substantially equivalent (SESE) to a predicate device. The product code IYO categorizes it under ‘System, Imaging, Pulsed Echo, Ultrasonic,’ confirming its classification as a Class II medical imaging device for diagnostic ultrasound imaging in radiology.
What storage and maintenance requirements should be followed to ensure proper functionality?
The manufacturer’s guidelines must be strictly followed for storage and maintenance to preserve functionality and compliance. Since this is a reusable device, it requires proper cleaning, sterilization (if applicable), and routine upkeep to meet imaging standards and ensure reliable performance in radiology settings.