Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1220](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1220) → JAO — Scanner, Fluorescent

# JAO · Scanner, Fluorescent

_Radiology · 21 CFR 892.1220 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAO

## Overview

- **Product Code:** JAO
- **Device Name:** Scanner, Fluorescent
- **Regulation:** [21 CFR 892.1220](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1220)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAO/K911749.md) | L-LINEX-RAY FLUORESCENCE | Montifore Medical Center | Aug 20, 1991 | SESE |
| [K900574](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAO/K900574.md) | ABIOMED BODY LEAD ANALYZER MODEL 200/20 | Abiomed, Inc. | Mar 15, 1990 | SESE |

## Top Applicants

- Montifore Medical Center — 1 clearance
- Abiomed, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAO](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAO)

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