Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1670](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1670) → HPW — Probe And Counter, Isotope, For Phosphorus 32

# HPW · Probe And Counter, Isotope, For Phosphorus 32

_Ophthalmic · 21 CFR 886.1670 · Class 2_

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

## Overview

- **Product Code:** HPW
- **Device Name:** Probe And Counter, Isotope, For Phosphorus 32
- **Regulation:** [21 CFR 886.1670](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1670)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

An ophthalmic isotope uptake probe is an AC-powered device intended to measure, by a probe which is placed in close proximity to the eye, the uptake of a radioisotope (phosphorus 32) by tumors to detect tumor masses on, around, or within the eye.

## Classification Rationale

Class II.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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