Cradle, Patient, Radiologic
The Radiologic Patient Cradle is a positioning device used in radiology departments to support and immobilize patients during diagnostic imaging procedures, ensuring consistent positioning and image quality. It is classified as FDA Class 1, the lowest risk category, subject only to general controls, with no premarket submission required. The product code is KXH, regulated under 21 CFR 892.1830, in the Radiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KXH
- Device Class
- FDA class 1
- Regulation Number
- 892.1830
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K122174 | PEDIATRIC POSITIONER PAD SET | Nov 16, 2012 | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) |
| K953246 | OCTOROLL | Sep 29, 1995 | Substantially Equivalent | Octostop, Inc. |
| K930124 | VARIANT OF OCTOSTOP AND OCTOPAQUE | Feb 09, 1994 | Substantially Equivalent | Octostop, Inc. |
| K933134 | SPECTRUM DG-P7000 PEDIATRIC CRADLE | Oct 07, 1993 | Substantially Equivalent | Spectrum X-Ray Corp. |
| K930357 | ACCESSORY TO UNIVERSAL OCTOPAQUE | Jul 13, 1993 | Substantially Equivalent | Octostop, Inc. |
| K884292 | STRETCHER TABLE | Mar 31, 1989 | Substantially Equivalent | Fischer Imaging Corp. |
| K863890 | MAMM-AIRE | Oct 14, 1986 | Substantially Equivalent | Ar Custom Medical Products, Ltd. |
| K840463 | DIGITAL CRADLE | Feb 21, 1984 | Substantially Equivalent | Spectrum X-Ray Corp. |
| K813561 | SPECTRUM PEDIATRIC CARDLE TABLE | Jan 29, 1982 | Substantially Equivalent | Spectrum X-Ray Corp. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.