FDA product code IYX: Camera, Scintillation (Gamma)
IYX is the FDA product code for camera, scintillation (gamma). It is a Class I device, regulated under 21 CFR 892.1100 and reviewed by the Radiology panel. FDA has cleared 130 510(k) submissions under IYX, 2 in the last five years, from 67 different applicants. The average 510(k) review took 92 days (median 70). FDA has posted 7 recalls for IYX devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Scintillation (Gamma) |
| Device class | Class I |
| Regulation | 21 CFR 892.1100 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IYX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 203 |
| 2023 | 2 | 384 |
Compare with all 510(k) review times · Search every IYX clearance
Top IYX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| General Electric Co. | 15 | 1993-03-18 |
| Siemens Gammasonics, Inc. | 11 | 1994-02-18 |
| Adac Laboratories | 6 | 1993-06-21 |
| Elscint, Inc. | 5 | 1994-02-18 |
| Toshiba Medical Systems | 5 | 1988-08-29 |
62 more applicants have IYX clearances. See the full list in Caduvo.
Most recent IYX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230221 | Versant Medical Physics and Radiation Safety | QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) | 2023-08-28 | 214 |
| K212587 | Radiopharmaceutical Imaging and Dosimetry, LLC | 3D-RD-S | 2023-02-22 | 555 |
| K163687 | Hermes Medical Solutions AB | OLINDA EXM | 2017-07-19 | 203 |
| K160933 | GE Healthcare | Discovery NM 750b Bopsy | 2016-11-18 | 228 |
| K162052 | General Equipment For Medical Imaging (Oncovision- | Sentinella 102, Sentinella 102 Horus | 2016-08-18 | 24 |
Recalls for IYX devices
7 product recalls in 5 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-12-10.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code IYX?
IYX is the FDA product code for camera, scintillation (gamma). It is a Class I device, regulated under 21 CFR 892.1100 and reviewed by the Radiology panel.
What device class is IYX?
Class I, regulation 21 CFR 892.1100. Typical premarket route: 510(k).
How long does a 510(k) take for product code IYX?
Across 130 cleared submissions the average was 92 days from receipt to decision (median 70).
Which companies have the most IYX clearances?
General Electric Co. (15); Siemens Gammasonics, Inc. (11); Adac Laboratories (6); Elscint, Inc. (5); Toshiba Medical Systems (5).
Have IYX devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2025-12-10.
Next steps
- Run an FDA pathway report with predicate devices for product code IYX
- Run a recall and safety report across every IYX manufacturer
- Watch product code IYX 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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