Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1560](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1560) → SGH — Ultrasound Imaging For Vascular Access For Hemodialysis

# SGH · Ultrasound Imaging For Vascular Access For Hemodialysis

_Radiology · 21 CFR 892.1560 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/SGH

## Overview

- **Product Code:** SGH
- **Device Name:** Ultrasound Imaging For Vascular Access For Hemodialysis
- **Regulation:** [21 CFR 892.1560](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1560)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251673](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/SGH/K251673.md) | X9 Ultrasound System | X9, Inc. | Oct 17, 2025 | SESE |

## Top Applicants

- X9, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/SGH](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/SGH)

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