KXH · Cradle, Patient, Radiologic
Radiology · 21 CFR 892.1830 · Class 1
Overview
| Product Code | KXH |
|---|---|
| Device Name | Cradle, Patient, Radiologic |
| Regulation | 21 CFR 892.1830 |
| Device Class | Class 1 |
| Review Panel | Radiology |
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 | PEDIATRIC POSITIONER PAD SET | Ge Healthcare Coils (Usa Instruments, Inc.) | Nov 16, 2012 | SESE |
| K953246 | OCTOROLL | Octostop, Inc. | Sep 29, 1995 | SESE |
| K930124 | VARIANT OF OCTOSTOP AND OCTOPAQUE | Octostop, Inc. | Feb 9, 1994 | SESE |
| K933134 | SPECTRUM DG-P7000 PEDIATRIC CRADLE | Spectrum X-Ray Corp. | Oct 7, 1993 | SESE |
| K930357 | ACCESSORY TO UNIVERSAL OCTOPAQUE | Octostop, Inc. | Jul 13, 1993 | SESE |
| K884292 | STRETCHER TABLE | Fischer Imaging Corp. | Mar 31, 1989 | SESE |
| K863890 | MAMM-AIRE | Ar Custom Medical Products, Ltd. | Oct 14, 1986 | SESE |
| K840463 | DIGITAL CRADLE | Spectrum X-Ray Corp. | Feb 21, 1984 | SESE |
| K813561 | 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
