Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1370](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1370) → IYP — Phantom, Anthropomorphic, Nuclear

# IYP · Phantom, Anthropomorphic, Nuclear

_Radiology · 21 CFR 892.1370 · Class 1_

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

## Overview

- **Product Code:** IYP
- **Device Name:** Phantom, Anthropomorphic, Nuclear
- **Regulation:** [21 CFR 892.1370](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1370)
- **Device Class:** 1
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A nuclear anthropomorphic phantom is a human tissue facsimile that contains a radioactive source or a cavity in which a radioactive sample can be inserted. It is intended to calibrate nuclear uptake probes or other medical instruments.

## 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K921878](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYP/K921878.md) | SCANMATE III | Circadian, Inc. | Sep 11, 1992 | SESE |
| [K844189](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYP/K844189.md) | LINEAR SCANNER PROBE ELSCINT LTD. TL-35 | Elscint, Inc. | Feb 25, 1985 | SESE |
| [K812893](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYP/K812893.md) | SUPERFLAB | Mick Radio-Nuclear Instruments, Inc. | Dec 8, 1981 | SESE |

## Top Applicants

- Mick Radio-Nuclear Instruments, Inc. — 1 clearance
- Elscint, Inc. — 1 clearance
- Circadian, Inc. — 1 clearance

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

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