Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1830](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1830) → KXH — Cradle, Patient, Radiologic

# KXH · Cradle, Patient, Radiologic

_Radiology · 21 CFR 892.1830 · Class 1_

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

## Overview

- **Product Code:** KXH
- **Device Name:** Cradle, Patient, Radiologic
- **Regulation:** [21 CFR 892.1830](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1830)
- **Device Class:** 1
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A radiologic patient cradle is a support device intended to be used for rotational positioning about the longitudinal axis of a patient during radiologic procedures.

## Classification Rationale

Class I (general controls). The device 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 (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K122174](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXH/K122174.md) | PEDIATRIC POSITIONER PAD SET | Ge Healthcare Coils (Usa Instruments, Inc.) | Nov 16, 2012 | SESE |
| [K953246](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXH/K953246.md) | OCTOROLL | Octostop, Inc. | Sep 29, 1995 | SESE |
| [K930124](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXH/K930124.md) | VARIANT OF OCTOSTOP AND OCTOPAQUE | Octostop, Inc. | Feb 9, 1994 | SESE |
| [K933134](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXH/K933134.md) | SPECTRUM DG-P7000 PEDIATRIC CRADLE | Spectrum X-Ray Corp. | Oct 7, 1993 | SESE |
| [K930357](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXH/K930357.md) | ACCESSORY TO UNIVERSAL OCTOPAQUE | Octostop, Inc. | Jul 13, 1993 | SESE |
| [K884292](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXH/K884292.md) | STRETCHER TABLE | Fischer Imaging Corp. | Mar 31, 1989 | SESE |
| [K863890](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXH/K863890.md) | MAMM-AIRE | Ar Custom Medical Products, Ltd. | Oct 14, 1986 | SESE |
| [K840463](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXH/K840463.md) | DIGITAL CRADLE | Spectrum X-Ray Corp. | Feb 21, 1984 | SESE |
| [K813561](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXH/K813561.md) | SPECTRUM PEDIATRIC CARDLE TABLE | Spectrum X-Ray Corp. | Jan 29, 1982 | SESE |

## Top Applicants

- Spectrum X-Ray Corp. — 3 clearances
- Octostop, Inc. — 3 clearances
- Ge Healthcare Coils (Usa Instruments, Inc.) — 1 clearance
- Fischer Imaging Corp. — 1 clearance
- Ar Custom Medical Products, Ltd. — 1 clearance

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

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