HPW · Probe And Counter, Isotope, For Phosphorus 32
Ophthalmic · 21 CFR 886.1670 · Class 2
Overview
| Product Code | HPW |
|---|---|
| Device Name | Probe And Counter, Isotope, For Phosphorus 32 |
| Regulation | 21 CFR 886.1670 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 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.
