5.0 Mhz Array Intravaginal Transducer
by Advanced Technology Laboratories, Inc. 2 variants
510(k) K891309
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK891309 | Date16 May 1989 | 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- Withdrawn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 5.0 Mhz Array Intravaginal Transducer is an ultrasonic transducer used in obstetric applications. It operates at a frequency of 5.0 Mhz and is designed for intravaginal use. The device is classified as a transducer, ultrasonic, obstetric. It is a medical device used to produce ultrasonic images.
The 5.0 Mhz Array Intravaginal Transducer is supplied by Advanced Technology Laboratories, Inc. and has received FDA 510K clearance. The device is classified as a Class II device and is subject to special controls. It is available with a product code of IYO and has undergone a traditional clearance process.
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Questions
AI-generated answers, 1 Oct 2026
What is the 5.0 Mhz Array Intravaginal Transducer used for?
The 5.0 Mhz Array Intravaginal Transducer is used in obstetric applications to produce ultrasonic images, providing valuable information for medical professionals.
How is the 5.0 Mhz Array Intravaginal Transducer supplied?
The device is supplied by Advanced Technology Laboratories, Inc., and is available with a product code of IYO.
Is the 5.0 Mhz Array Intravaginal Transducer a single-use or reusable device?
The description does not specify whether the device is single-use or reusable, but it is designed for intravaginal use in obstetric applications.
What is the regulatory status of the 5.0 Mhz Array Intravaginal Transducer?
The device has received FDA 510K clearance, indicating that it is substantially equivalent to a predicate device and has undergone a traditional clearance process.