FDA product code IWI: Source, Isotope, Sealed, Gold, Titanium, Platinum
IWI is the FDA product code for source, isotope, sealed, gold, titanium, platinum. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel. FDA has cleared 6 510(k) submissions under IWI, from 6 different applicants. The average 510(k) review took 188 days (median 207).
Classification
| Field | Value |
|---|---|
| Device name | Source, Isotope, Sealed, Gold, Titanium, Platinum |
| Device class | Class II |
| Regulation | 21 CFR 892.5730 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every IWI clearance
Top IWI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ml Strategies, Inc. | 1 | 1998-07-02 |
| Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1 | 1994-09-02 |
| Best Industries | 1 | 1991-08-09 |
| Cis-Us, Inc. | 1 | 1989-04-14 |
| Theragenics Corp. | 1 | 1987-12-22 |
1 more applicants have IWI clearances. See the full list in Caduvo.
Most recent IWI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973363 | Ml Strategies, Inc. | NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 | 1998-07-02 | 297 |
| K940632 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | I-125 RAPID STRAND | 1994-09-02 | 200 |
| K912170 | Best Industries | RADIOACTIVE IODINE-125 SOURCES | 1991-08-09 | 85 |
| K882449 | Cis-Us, Inc. | CESIUM 137 SOURCE, MODEL CSM-40 | 1989-04-14 | 304 |
| K874787 | Theragenics Corp. | MODIFIED PALLADIUM SEED MODEL 100 | 1987-12-22 | 29 |
Recalls for IWI devices
openFDA lists no recalls for product code IWI.
Frequently asked questions
What is FDA product code IWI?
IWI is the FDA product code for source, isotope, sealed, gold, titanium, platinum. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel.
What device class is IWI?
Class II, regulation 21 CFR 892.5730. Typical premarket route: 510(k).
How long does a 510(k) take for product code IWI?
Across 6 cleared submissions the average was 188 days from receipt to decision (median 207).
Which companies have the most IWI clearances?
Ml Strategies, Inc. (1); Medi-Physics Inc. Dba Nycomed Amersham Imaging (1); Best Industries (1); Cis-Us, Inc. (1); Theragenics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IWI
- Run a recall and safety report across every IWI manufacturer
- Watch product code IWI 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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