IYW · Scanner, Rectilinear, Nuclear
Radiology · 21 CFR 892.1300 · Class 1
Overview
| Product Code | IYW |
|---|---|
| Device Name | Scanner, Rectilinear, Nuclear |
| Regulation | 21 CFR 892.1300 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions with respect to the patient. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K944684 | POLYSCAN DIGITAL SCANNER | Mse Medizintechnik GmbH & Co. KG | May 15, 1995 | SESE |
| K895799 | RECTILINEAR SCANNER MODEL #187-270 | Atomic Products Corp. | Feb 1, 1990 | SESE |
| K882453 | POLYSCAN DIGITAL SCANNER | Medical and Scientific Enterprises, Inc. | Nov 23, 1988 | SESE |
| K780395 | IMAGER, BODY SECTION, RADIONUCLIDE | Union Carbide Corp. | Mar 31, 1978 | SESE |
Top Applicants
- Union Carbide Corp. — 1 clearance
- Mse Medizintechnik GmbH & Co. KG — 1 clearance
- Medical and Scientific Enterprises, Inc. — 1 clearance
- Atomic Products Corp. — 1 clearance
