FDA product code IZW: Collimator, Automatic, Radiographic
IZW is the FDA product code for collimator, automatic, radiographic. It is a Class II device, regulated under 21 CFR 892.1610 and reviewed by the Radiology panel. FDA has cleared 23 510(k) submissions under IZW, from 17 different applicants. The average 510(k) review took 74 days (median 56). FDA has posted 3 recalls for IZW devices.
Classification
| Field | Value |
|---|---|
| Device name | Collimator, Automatic, 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 IZW clearance
Top IZW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ralco S.R.L. | 3 | 2009-07-14 |
| Shimadzu Corp. | 2 | 2010-09-20 |
| Omega Medical Imaging, Inc. | 2 | 2010-02-03 |
| Philips Medical Systems, Inc. | 2 | 1999-03-15 |
| Shimadzu Medical Systems | 2 | 1992-04-16 |
12 more applicants have IZW clearances. See the full list in Caduvo.
Most recent IZW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101039 | Shimadzu Corp. | SHIMADZU COLLIMATOR R-300 | 2010-09-20 | 159 |
| K093572 | Omega Medical Imaging, Inc. | R650 QDASM COLLIMATOR | 2010-02-03 | 77 |
| K090578 | Shimadzu Corp. | SHIMADZU COLLIMATOR R-30H | 2009-11-06 | 248 |
| K091517 | Ralco S.R.L. | RALCO, MODEL R225 ACS | 2009-07-14 | 53 |
| K083029 | Ralco S.R.L. | MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR | 2008-12-05 | 56 |
Recalls for IZW devices
3 product recalls in 3 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 IZW?
IZW is the FDA product code for collimator, automatic, radiographic. It is a Class II device, regulated under 21 CFR 892.1610 and reviewed by the Radiology panel.
What device class is IZW?
Class II, regulation 21 CFR 892.1610. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IZW?
Across 23 cleared submissions the average was 74 days from receipt to decision (median 56).
Which companies have the most IZW clearances?
Ralco S.R.L. (3); Shimadzu Corp. (2); Omega Medical Imaging, Inc. (2); Philips Medical Systems, Inc. (2); Shimadzu Medical Systems (2).
Have IZW devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2011-10-28.
Next steps
- Run an FDA pathway report with predicate devices for product code IZW
- Run a recall and safety report across every IZW manufacturer
- Watch product code IZW 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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