Scanner, Rectilinear, Nuclear
A nuclear rectilinear scanner is a device used in nuclear medicine to detect and map the distribution of radioactive tracers within the body by moving a radiation detector systematically across the patient, producing static scintigraphic images. It is classified as FDA Class 1, the lowest risk designation, subject only to general controls without a premarket notification requirement. The product code is IYW, regulated under 21 CFR 892.1300, within the Radiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- IYW
- Device Class
- FDA class 1
- Regulation Number
- 892.1300
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K944684 | POLYSCAN DIGITAL SCANNER | May 15, 1995 | Substantially Equivalent | Mse Medizintechnik GmbH & Co. KG |
| K895799 | RECTILINEAR SCANNER MODEL #187-270 | Feb 01, 1990 | Substantially Equivalent | Atomic Products Corp. |
| K882453 | POLYSCAN DIGITAL SCANNER | Nov 23, 1988 | Substantially Equivalent | Medical and Scientific Enterprises, Inc. |
| K780395 | IMAGER, BODY SECTION, RADIONUCLIDE | Mar 31, 1978 | Substantially Equivalent | Union Carbide Corp. |