LogicScan 64 LogicScan 128
by Telemed Lithuania 510(k)
510(k) K113184
Product code IYN
Overview
This device is an ultrasound system. It is a Class II ultrasound system manufactured by Telemed.
It has received FDA 510(k) clearance (K113184) and is used in radiology. The system is supplied as a non-sterile, reusable device intended for use in clinical settings. No information regarding MRI safety, specific sizes, or storage conditions is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113184 | Date26 Jan 2012 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Telemed
Questions
What is the LOGICSCAN 64 LOGICSCAN 128 used for?
The LOGICSCAN 64 LOGICSCAN 128 is an ultrasound system used in radiology for clinical imaging, as indicated by its FDA 510(k) clearance and product code IYN, which corresponds to ultrasonic pulsed echo imaging systems.
Is the LOGICSCAN 64 LOGICSCAN 128 sterile or non-sterile, and is it single-use or reusable?
The device is supplied as non-sterile and reusable, intended for repeated use in clinical settings after appropriate cleaning and disinfection, as stated in the device description.
What regulatory clearance does the LOGICSCAN 64 LOGICSCAN 128 have?
The LOGICSCAN 64 LOGICSCAN 128 has received FDA 510(k) clearance under submission number K113184, classified as a Class II device with a traditional clearance pathway and substantially equivalent determination.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K113184