Bed, Scanning, Nuclear
A nuclear scanning bed is a patient support table designed for use with nuclear medicine imaging systems, positioning and transporting the patient through the detector field during whole-body or regional scintigraphic scanning. It is classified as FDA Class 1, reflecting the lowest level of regulatory oversight, with only general controls required. The product code is IYZ, regulated under 21 CFR 892.1350, within the Radiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- IYZ
- Device Class
- FDA class 1
- Regulation Number
- 892.1350
- 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 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K920962 | MULTIPLE ACCESSORY TO GAMMA CAMERAS | Apr 17, 1992 | Substantially Equivalent | Nu Age Products |
| K915541 | SPECT TABLE, MODEL #056-760 | Jan 17, 1992 | Substantially Equivalent | Atomic Products Corp. |
| K911691 | XYZ CRANK IMAGING TABLE | Aug 09, 1991 | Substantially Equivalent | Med-Tron Products, Inc. |
| K912481 | ECT CARBON FIBER PALLET, MODIFICATION | Aug 02, 1991 | Substantially Equivalent | Siemens Gammasonics, Inc. |
| K912286 | CARDIAC SPECT PALLET | Aug 02, 1991 | Substantially Equivalent | Siemens Gammasonics, Inc. |
| K912181 | E-Z LIFT CRANK IMAGING TABLE | Jul 17, 1991 | Substantially Equivalent | Med-Tron Products, Inc. |
| K912135 | XY IMAGING TABLE | Jul 17, 1991 | Substantially Equivalent | Med-Tron Products, Inc. |
| K911564 | E-Z LIFT IMAGING TABLE WITH FOOT PUMP | Jul 15, 1991 | Substantially Equivalent | Med-Tron Products, Inc. |
| K911561 | XYZ IMAGING TABLE WITH FOOT PUMP | Jul 15, 1991 | Substantially Equivalent | Med-Tron Products, Inc. |
| K903901 | SCANNING COT | Sep 21, 1990 | Substantially Equivalent | Med-Tron Products, Inc. |
| K903767 | ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL | Sep 07, 1990 | Substantially Equivalent | Siemens Gammasonics, Inc. |
| K893826 | QRSYSTEMS H.D. NUCLEAR IMAGING TABLE | Aug 02, 1989 | Substantially Equivalent | Qrsystems, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.