Scanner, Whole Body, Nuclear
A nuclear whole body scanner is a device used in nuclear medicine to detect and map the distribution of radioactive tracers throughout the entire body, producing scintigraphic images useful for identifying metastatic disease, infection, or other systemic conditions. It is classified as FDA Class 1, the lowest risk designation, subject only to general controls with no premarket notification requirement. The product code is JAM, regulated under 21 CFR 892.1330, within the Radiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JAM
- Device Class
- FDA class 1
- Regulation Number
- 892.1330
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K842895 | WBA - I.R.I.S. | Aug 27, 1984 | Substantially Equivalent | Siemens Gammasonics, Inc. |
| K841996 | MAXICAMERA 400T W/BODY CONTOUR TOMOGRA | Jul 16, 1984 | Substantially Equivalent | General Electric Co. |
| K770530 | CLEON IMAGER | Apr 05, 1977 | Substantially Equivalent | Union Carbide Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.