Phantom, Anthropomorphic, Nuclear
A nuclear anthropomorphic phantom is a device that simulates human tissue and anatomy for quality assurance and calibration of nuclear medicine imaging systems, allowing evaluation of scanner performance under realistic conditions. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and not requiring premarket notification. The product code is IYP, regulated under 21 CFR 892.1370, within the Radiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- IYP
- Device Class
- FDA class 1
- Regulation Number
- 892.1370
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K921878 | SCANMATE III | Sep 11, 1992 | Substantially Equivalent | Circadian, Inc. |
| K844189 | LINEAR SCANNER PROBE ELSCINT LTD. TL-35 | Feb 25, 1985 | Substantially Equivalent | Elscint, Inc. |
| K812893 | SUPERFLAB | Dec 08, 1981 | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.