Mark III Ultrasonic Scanning System
by Advanced Technology Laboratories, Inc. 3 variants
510(k) K802437
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK802437 | Date15 Jan 1981 | 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- Withdrawn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, 1 Oct 2026
The Mark III Ultrasonic Scanning System is a diagnostic ultrasound device designed for imaging internal body structures using high-frequency sound waves. It falls under the category of ultrasound imaging systems, enabling real-time visualization of organs, tissues, and blood flow for diagnostic purposes in radiology. This system generates and processes ultrasound images to assist clinicians in assessing anatomical and pathological conditions. Its primary function is to provide detailed internal imaging without the use of ionizing radiation.
This device is intended for use in radiology departments within healthcare settings and has received FDA 510(k) clearance under the product code IYO. It is classified as a Class II medical device and was cleared for marketing in 1981. The system is not described as single-use or reusable in the provided data, nor are there details regarding sterility or MRI safety. The Mark III system is supplied as a standalone imaging unit, with no explicit storage or handling instructions provided in the specifications.
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Questions
AI-generated answers, 1 Oct 2026
What is the Mark III Ultrasonic Scanning System used for?
The Mark III Ultrasonic Scanning System is designed for diagnostic imaging in radiology departments. It uses high-frequency sound waves to create real-time images of internal body structures, such as organs, tissues, and blood flow. This allows clinicians to assess anatomical and pathological conditions without exposing patients to ionizing radiation, making it suitable for evaluating soft tissues, fetal imaging, and vascular studies.
How is the Mark III Ultrasonic Scanning System supplied?
The Mark III system is supplied as a standalone imaging unit, meaning it is intended for installation in a clinical setting rather than as a portable or modular component. The device is not explicitly described as single-use or reusable, so its operational lifespan depends on maintenance and manufacturer guidelines. No specific storage or handling instructions are provided in the available data.
Is the Mark III system reusable or single-use?
The provided data does not specify whether the Mark III Ultrasonic Scanning System is reusable or single-use. Typically, ultrasound machines like this are designed for repeated use in clinical environments, with components such as probes potentially being reusable or disposable depending on manufacturer recommendations. For precise usage instructions, refer to the device’s operational manual or consult the manufacturer.
What regulatory approval does the Mark III system hold?
The Mark III Ultrasonic Scanning System holds FDA 510(k) clearance, which means it has been determined to be substantially equivalent to a legally marketed device already on the market. It was cleared under product code IYO and classified as a Class II medical device. The clearance was granted in 1981, indicating its long-standing use in diagnostic radiology.
Can the Mark III system be used in MRI environments?
The provided data does not mention whether the Mark III Ultrasonic Scanning System is MRI-safe or compatible with magnetic resonance imaging environments. If MRI safety is a concern, it is critical to verify this information with the manufacturer or consult the device’s technical specifications and safety documentation to avoid potential interference or hazards.