JAO · Scanner, Fluorescent
Radiology · 21 CFR 892.1220 · Class 2
Overview
| Product Code | JAO |
|---|---|
| Device Name | Scanner, Fluorescent |
| Regulation | 21 CFR 892.1220 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A fluorescent scanner is a device intended to measure the induced fluorescent radiation in the body by exposing the body to certain x-rays or low-energy gamma rays. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K911749 | L-LINEX-RAY FLUORESCENCE | Montifore Medical Center | Aug 20, 1991 | SESE |
| K900574 | ABIOMED BODY LEAD ANALYZER MODEL 200/20 | Abiomed, Inc. | Mar 15, 1990 | SESE |
Top Applicants
- Montifore Medical Center — 1 clearance
- Abiomed, Inc. — 1 clearance
