FDA product code IZX: Collimator, Manual, Radiographic
IZX is the FDA product code for collimator, manual, radiographic. It is a Class II device, regulated under 21 CFR 892.1610 and reviewed by the Radiology panel. FDA has cleared 17 510(k) submissions under IZX, from 14 different applicants. The average 510(k) review took 62 days (median 50). FDA has posted 4 recalls for IZX devices.
Classification
| Field | Value |
|---|---|
| Device name | Collimator, Manual, Radiographic |
| Device class | Class II |
| Regulation | 21 CFR 892.1610 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IZX clearance
Top IZX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shimadzu Corp. | 3 | 2010-08-26 |
| Advantech | 2 | 1990-02-06 |
| Ralco S.R.L. | 1 | 2011-08-10 |
| Dynarad Corp. | 1 | 1998-05-06 |
| Wuestec Medical, Inc. | 1 | 1997-12-22 |
9 more applicants have IZX clearances. See the full list in Caduvo.
Most recent IZX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110856 | Ralco S.R.L. | RALCO | 2011-08-10 | 135 |
| K101036 | Shimadzu Corp. | SHIMADZU COLLIMATOR R-20J | 2010-08-26 | 134 |
| K042840 | Shimadzu Corp. | SHIMADZU COLLIMATOR R-20J | 2004-12-03 | 50 |
| K031771 | Shimadzu Corp. | SHIMADZU COLLIMATOR R-30H | 2003-08-21 | 73 |
| K981267 | Dynarad Corp. | FACTS MONOBLOCK | 1998-05-06 | 29 |
Recalls for IZX devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-10-28.
Frequently asked questions
What is FDA product code IZX?
IZX is the FDA product code for collimator, manual, radiographic. It is a Class II device, regulated under 21 CFR 892.1610 and reviewed by the Radiology panel.
What device class is IZX?
Class II, regulation 21 CFR 892.1610. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IZX?
Across 17 cleared submissions the average was 62 days from receipt to decision (median 50).
Which companies have the most IZX clearances?
Shimadzu Corp. (3); Advantech (2); Ralco S.R.L. (1); Dynarad Corp. (1); Wuestec Medical, Inc. (1).
Have IZX devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2011-10-28.
Next steps
- Run an FDA pathway report with predicate devices for product code IZX
- Run a recall and safety report across every IZX manufacturer
- Watch product code IZX 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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