FDA product code IZD: Probe, Uptake, Nuclear
IZD is the FDA product code for probe, uptake, nuclear. It is a Class I device, regulated under 21 CFR 892.1320 and reviewed by the Radiology panel. FDA has cleared 30 510(k) submissions under IZD, from 15 different applicants. The average 510(k) review took 106 days (median 84). FDA has posted 10 recalls for IZD devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Probe, Uptake, Nuclear |
| Device class | Class I |
| Regulation | 21 CFR 892.1320 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IZD clearance
Top IZD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neoprobe Corp. | 5 | 1997-06-26 |
| Care Wise Medical Products Corp. | 4 | 1998-08-25 |
| Surgiceye GmbH | 3 | 2014-04-11 |
| Capintec Instruments, Inc. | 3 | 1993-05-18 |
| Radiation Monitoring Devices, Inc. | 2 | 1999-07-02 |
10 more applicants have IZD clearances. See the full list in Caduvo.
Most recent IZD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K133781 | Surgiceye GmbH | DECLIPSESPECT LAPAROSCOPY | 2014-04-11 | 120 |
| K123917 | Surgiceye GmbH | DECLIPSESPECT VIEWER | 2013-01-25 | 37 |
| K101887 | Surgiceye GmbH | CONFIDENT SURGERY SUITE 300, MODEL CSS300 | 2011-03-22 | 259 |
| K013751 | Silicon Instruments Gmhb | HANDHELD GAMMA FINDER (HGF) | 2002-02-06 | 85 |
| K983768 | Radiation Monitoring Devices, Inc. | MODIFICATION TO GAMMA GUIDANCE SYSTEM | 1999-07-02 | 249 |
Recalls for IZD devices
10 product recalls in 7 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-07-20.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2020 | 2 |
| 2023 | 1 |
| 2024 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code IZD?
IZD is the FDA product code for probe, uptake, nuclear. It is a Class I device, regulated under 21 CFR 892.1320 and reviewed by the Radiology panel.
What device class is IZD?
Class I, regulation 21 CFR 892.1320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IZD?
Across 30 cleared submissions the average was 106 days from receipt to decision (median 84).
Which companies have the most IZD clearances?
Neoprobe Corp. (5); Care Wise Medical Products Corp. (4); Surgiceye GmbH (3); Capintec Instruments, Inc. (3); Radiation Monitoring Devices, Inc. (2).
Have IZD devices been recalled?
Yes: 10 product recalls across 7 recall events; the most recent began 2026-07-20.
Next steps
- Run an FDA pathway report with predicate devices for product code IZD
- Run a recall and safety report across every IZD manufacturer
- Watch product code IZD 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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