FDA product code IYP: Phantom, Anthropomorphic, Nuclear
IYP is the FDA product code for phantom, anthropomorphic, nuclear. It is a Class I device, regulated under 21 CFR 892.1370 and reviewed by the Radiology panel. FDA has cleared 3 510(k) submissions under IYP, from 3 different applicants. The average 510(k) review took 105 days (median 118).
Classification
| Field | Value |
|---|---|
| Device name | Phantom, Anthropomorphic, Nuclear |
| Device class | Class I |
| Regulation | 21 CFR 892.1370 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IYP clearance
Top IYP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Circadian, Inc. | 1 | 1992-09-11 |
| Elscint, Inc. | 1 | 1985-02-25 |
| Mick Radio-Nuclear Instruments, Inc. | 1 | 1981-12-08 |
Most recent IYP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921878 | Circadian, Inc. | SCANMATE III | 1992-09-11 | 144 |
| K844189 | Elscint, Inc. | LINEAR SCANNER PROBE ELSCINT LTD. TL-35 | 1985-02-25 | 118 |
| K812893 | Mick Radio-Nuclear Instruments, Inc. | SUPERFLAB | 1981-12-08 | 54 |
Recalls for IYP devices
openFDA lists no recalls for product code IYP.
Frequently asked questions
What is FDA product code IYP?
IYP is the FDA product code for phantom, anthropomorphic, nuclear. It is a Class I device, regulated under 21 CFR 892.1370 and reviewed by the Radiology panel.
What device class is IYP?
Class I, regulation 21 CFR 892.1370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IYP?
Across 3 cleared submissions the average was 105 days from receipt to decision (median 118).
Which companies have the most IYP clearances?
Circadian, Inc. (1); Elscint, Inc. (1); Mick Radio-Nuclear Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IYP
- Run a recall and safety report across every IYP manufacturer
- Watch product code IYP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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