FDA product code IZH: System, X-Ray, Mammographic
IZH is the FDA product code for system, x-ray, mammographic. It is a Class II device, regulated under 21 CFR 892.1710 and reviewed by the Radiology panel. FDA has cleared 176 510(k) submissions under IZH, from 87 different applicants. The average 510(k) review took 114 days (median 77). FDA has posted 14 recalls for IZH devices.
Classification
| Field | Value |
|---|---|
| Device name | System, X-Ray, Mammographic |
| Device class | Class II |
| Regulation | 21 CFR 892.1710 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IZH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 28 |
| 2020 | 1 | 53 |
| 2021 | 1 | 226 |
Compare with all 510(k) review times · Search every IZH clearance
Top IZH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Planmed OY | 11 | 2004-11-19 |
| Lorad Corp. | 11 | 1999-09-03 |
| Elscint, Inc. | 10 | 1998-12-11 |
| Fischer Imaging Corp. | 8 | 2004-10-29 |
| Bennett X-Ray Corp. | 7 | 1997-01-10 |
82 more applicants have IZH clearances. See the full list in Caduvo.
Most recent IZH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203509 | Ims Giotto S.P.A. | SMART FINDER | 2021-07-14 | 226 |
| K202294 | Hologic, Inc. | Affirm Contrast Biopsy | 2020-10-05 | 53 |
| K191495 | Fujifilm Corporation | Biopsy Positioner | 2019-07-03 | 28 |
| K161575 | Hologic | Affirm Lateral Arm Upright Biopsy Accessory | 2016-08-10 | 64 |
| K161920 | Precision Dynamics Corporation | Comfort Cover | 2016-07-15 | 2 |
Recalls for IZH devices
14 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-05-13.
Frequently asked questions
What is FDA product code IZH?
IZH is the FDA product code for system, x-ray, mammographic. It is a Class II device, regulated under 21 CFR 892.1710 and reviewed by the Radiology panel.
What device class is IZH?
Class II, regulation 21 CFR 892.1710. Typical premarket route: 510(k).
How long does a 510(k) take for product code IZH?
Across 176 cleared submissions the average was 114 days from receipt to decision (median 77).
Which companies have the most IZH clearances?
Planmed OY (11); Lorad Corp. (11); Elscint, Inc. (10); Fischer Imaging Corp. (8); Bennett X-Ray Corp. (7).
Have IZH devices been recalled?
Yes: 14 product recalls across 7 recall events; the most recent began 2014-05-13.
Next steps
- Run an FDA pathway report with predicate devices for product code IZH
- Run a recall and safety report across every IZH manufacturer
- Watch product code IZH 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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