IYP · Phantom, Anthropomorphic, Nuclear
Radiology · 21 CFR 892.1370 · Class 1
Overview
| Product Code | IYP |
|---|---|
| Device Name | Phantom, Anthropomorphic, Nuclear |
| Regulation | 21 CFR 892.1370 |
| Device Class | Class 1 |
| Review Panel | Radiology |
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 | SCANMATE III | Circadian, Inc. | Sep 11, 1992 | SESE |
| K844189 | LINEAR SCANNER PROBE ELSCINT LTD. TL-35 | Elscint, Inc. | Feb 25, 1985 | SESE |
| K812893 | 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
