PSW · High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
Radiology · 21 CFR 892.1570 · Class 2
Overview
| Product Code | PSW |
|---|---|
| Device Name | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
Classification Rationale
Class II.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233049 | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator | Cs Medical, LLC | Nov 21, 2023 | SESE |
| K230381 | Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator | Cs Medical, LLC | Jun 7, 2023 | SESE |
| K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant | Cs Medical, LLC | Apr 1, 2020 | SESE |
| K182891 | TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants | Cs Medical, LLC | Apr 12, 2019 | SESE |
| K160921 | CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant | Cs Medical, LLC | Nov 3, 2016 | SESE |
| K150504 | GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor | Pci Medical, Inc. | Nov 16, 2015 | SESE |
| K051305 | CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 | Cs Medical, LLC | Aug 18, 2005 | SESE |
Top Applicants
- Cs Medical, LLC — 6 clearances
- Pci Medical, Inc. — 1 clearance
