JAM · Scanner, Whole Body, Nuclear
Radiology · 21 CFR 892.1330 · Class 1
Overview
| Product Code | JAM |
|---|---|
| Device Name | Scanner, Whole Body, Nuclear |
| Regulation | 21 CFR 892.1330 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A nuclear whole body scanner is a device intended to measure and image the distribution of radionuclides in the body by means of a wide-aperture detector whose position moves in one direction 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 § 892.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K842895 | WBA - I.R.I.S. | Siemens Gammasonics, Inc. | Aug 27, 1984 | SESE |
| K841996 | MAXICAMERA 400T W/BODY CONTOUR TOMOGRA | General Electric Co. | Jul 16, 1984 | SESE |
| K770530 | CLEON IMAGER | Union Carbide Corp. | Apr 5, 1977 | SESE |
Top Applicants
- Union Carbide Corp. — 1 clearance
- Siemens Gammasonics, Inc. — 1 clearance
- General Electric Co. — 1 clearance
