JWM · System, Tomographic, Nuclear
Radiology · 21 CFR 892.1310 · Class 2
Overview
| Product Code | JWM |
|---|---|
| Device Name | System, Tomographic, Nuclear |
| Regulation | 21 CFR 892.1310 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of devices may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K914350 | ICON COMPUTER SYSTEM | Siemens Gammasonics, Inc. | Nov 22, 1991 | SESE |
| K904599 | D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM | Digital Design, Inc. | Apr 23, 1991 | SESE |
| K903315 | ICON | Siemens Gammasonics, Inc. | Jan 9, 1991 | SESE |
| K901545 | GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM | Toshiba America Medical Systems, In.C | Jun 26, 1990 | SESE |
| K874473 | ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM | Adac Laboratories | Jul 18, 1988 | SESE |
| K873075 | ADAC MODEL ARC-5000, GAMMA CAMERA | Adac Laboratories | Oct 30, 1987 | SESE |
| K851685 | DIGITAL GAMMA CAMERA GCA 601 E | Toshiba Medical Systems | Jun 14, 1985 | SESE |
| K850885 | STARCAM DATA ACQUISITION & PROCESSING SYS H3300C | General Electric Co. | Jun 6, 1985 | SESE |
| K851687 | JUMBO DIGITAL GAMMACAMERA GCA-90B | Toshiba Medical Systems | Jun 5, 1985 | SESE |
| K851686 | DIGITAL GAMMA CAMERA GCA 501S | Toshiba Medical Systems | Jun 5, 1985 | SESE |
| K841905 | DOT-A, DOT-AR PXP-E, PXP-ER | Siemens Gammasonics, Inc. | Aug 9, 1984 | SESE |
| K832737 | ECT PROCESSOR | Siemens Gammasonics, Inc. | Sep 29, 1983 | SESE |
| K812966 | 400T ECT SOFTWARE | General Electric Co. | Nov 24, 1981 | SESE |
| K810873 | STAR | Intl. General Electric Co. | Apr 23, 1981 | SESE |
| K801917 | STAR | General Electric Co. | Sep 16, 1980 | SESE |
| K780369 | MODUMED MUGE | Medtronic Vascular | Mar 14, 1978 | SESE |
| K780368 | MODUMED MUGX | Medtronic Vascular | Mar 14, 1978 | SESE |
Top Applicants
- Siemens Gammasonics, Inc. — 4 clearances
- Toshiba Medical Systems — 3 clearances
- General Electric Co. — 3 clearances
- Medtronic Vascular — 2 clearances
- Adac Laboratories — 2 clearances
