FDA product code IWE: Monitor, Patient Position, Light-Beam
IWE is the FDA product code for monitor, patient position, light-beam. It is a Class I device, regulated under 21 CFR 892.5780 and reviewed by the Radiology panel. FDA has cleared 28 510(k) submissions under IWE, from 14 different applicants. The average 510(k) review took 89 days (median 88). FDA has posted 8 recalls for IWE devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Patient Position, Light-Beam |
| Device class | Class I |
| Regulation | 21 CFR 892.5780 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IWE clearance
Top IWE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtec, Inc. | 7 | 1996-05-24 |
| Diacor, Inc. | 4 | 1995-10-23 |
| A2j, Inc. | 3 | 1993-10-08 |
| Cp Bio-Medical Corp. | 3 | 1993-06-04 |
| Medical Alignment Systems | 2 | 1992-11-16 |
9 more applicants have IWE clearances. See the full list in Caduvo.
Most recent IWE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K152303 | Gammex, Inc. | CT Sim Laser System | 2015-09-11 | 28 |
| K973162 | Hogan & Hartson | DUAL RADIATION TARGETING SYSTEM DRTS DRAPE | 1997-11-20 | 90 |
| K955236 | Medtec, Inc. | GREEN TEC-2100 | 1996-05-24 | 192 |
| K954414 | Diacor, Inc. | CENTRALITE BACKPOINTER | 1995-10-23 | 32 |
| K950293 | Medtec, Inc. | TEC-2110 GREEN LASER MODEL MT-HNG | 1995-08-18 | 205 |
Recalls for IWE devices
8 product recalls in 8 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-08-27.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2023 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code IWE?
IWE is the FDA product code for monitor, patient position, light-beam. It is a Class I device, regulated under 21 CFR 892.5780 and reviewed by the Radiology panel.
What device class is IWE?
Class I, regulation 21 CFR 892.5780. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IWE?
Across 28 cleared submissions the average was 89 days from receipt to decision (median 88).
Which companies have the most IWE clearances?
Medtec, Inc. (7); Diacor, Inc. (4); A2j, Inc. (3); Cp Bio-Medical Corp. (3); Medical Alignment Systems (2).
Have IWE devices been recalled?
Yes: 8 product recalls across 8 recall events; the most recent began 2025-08-27.
Next steps
- Run an FDA pathway report with predicate devices for product code IWE
- Run a recall and safety report across every IWE manufacturer
- Watch product code IWE 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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