IYO · System, Imaging, Pulsed Echo, Ultrasonic
Radiology · 21 CFR 892.1560 · Class 2
Overview
| Product Code | IYO |
|---|---|
| Device Name | System, Imaging, Pulsed Echo, Ultrasonic |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 892)
Showing 20 most recent of 892 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252237 | EdgeFlow UW20 | Edgecare, Inc. | Apr 17, 2026 | SESE |
| K254021 | Accuro XV | Rivanna Medical, Inc. | Apr 9, 2026 | SESE |
| K253898 | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | Mar 4, 2026 | SESE |
| K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | Feb 24, 2026 | SESE |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited | Feb 6, 2026 | SESE |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. | Sep 30, 2025 | SESE |
| K250381 | Deepsight NeedleVue LC1 Ultrasound System | DeepSight Technology, Inc. | Aug 1, 2025 | SESE |
| K243227 | B-Scan | Accutome, Inc. Doing Business AS Keeler USA | Jul 11, 2025 | SESE |
| K251728 | Velacur One (LI-1100) | Sonic Incytes Medical Corp | Jun 26, 2025 | SESE |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | Wuxi Hisky Medical Technologies Co., Ltd. | Jun 17, 2025 | SESE |
| K243937 | Accuro 3S | Rivanna Medical, Inc. | May 23, 2025 | SESE |
| K243479 | EchoGuide (Version 1) | Sonavex, Inc. | Apr 23, 2025 | SESE |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | Eieling Technology (Shenzhen) Limited | Nov 19, 2024 | SESE |
| K241029 | SpineUs System | Verdure Imaging | Oct 7, 2024 | SESE |
| K233977 | Velacur | Sonic Incytes | Sep 4, 2024 | SESE |
| K233579 | SC1 Handheld Ultrasound Imaging system (Model: SC1) | Fcu Co., Ltd. | Jun 26, 2024 | SESE |
| K233613 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | Jun 12, 2024 | SESE |
| K232895 | B-Ultrasound Diagnostic System | Contec Medical Systems Co.,Ltd | May 3, 2024 | SESE |
| K232302 | Pocket III | Quantel Medical | Apr 26, 2024 | SESE |
| K231677 | EdgeFlow UH10 | Edgecare, Inc. | Mar 6, 2024 | SESE |
Top Applicants
- Siemens Medical Solutions USA, Inc. — 31 clearances
- General Electric Co. — 21 clearances
- Advanced Technology Laboratories, Inc. — 20 clearances
- Volcano Corporation — 19 clearances
- Hewlett-Packard Co. — 14 clearances
