FDA product code IYB: Tube Mount, X-Ray, Diagnostic
IYB is the FDA product code for tube mount, x-ray, diagnostic. It is a Class I device, regulated under 21 CFR 892.1770 and reviewed by the Radiology panel. FDA has cleared 40 510(k) submissions under IYB, from 24 different applicants. The average 510(k) review took 83 days (median 44). FDA has posted 13 recalls for IYB devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tube Mount, X-Ray, Diagnostic |
| Device class | Class I |
| Regulation | 21 CFR 892.1770 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Top IYB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fischer Imaging Corp. | 5 | 1990-02-26 |
| Shimadzu Medical Systems | 4 | 1992-12-07 |
| Bennett X-Ray Corp. | 3 | 1992-12-17 |
| Radkor, Inc. | 3 | 1988-10-19 |
| Wuestec Medical, Inc. | 2 | 1996-03-27 |
19 more applicants have IYB clearances. See the full list in Caduvo.
Most recent IYB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935123 | Wuestec Medical, Inc. | SUPERSTAND 300 | 1996-03-27 | 881 |
| K946261 | Scott Imaging Intl., Inc. | MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 | 1995-02-15 | 64 |
| K941017 | Acoma Medical Imaging, Inc. | F/C/W TUBESTAND | 1994-07-29 | 148 |
| K941004 | Acoma Medical Imaging, Inc. | CTS SYSTEM | 1994-07-29 | 150 |
| K940442 | Xri, Inc. | MPR-814 | 1994-06-09 | 128 |
Recalls for IYB devices
13 product recalls in 12 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-10-16.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code IYB?
IYB is the FDA product code for tube mount, x-ray, diagnostic. It is a Class I device, regulated under 21 CFR 892.1770 and reviewed by the Radiology panel.
What device class is IYB?
Class I, regulation 21 CFR 892.1770. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IYB?
Across 40 cleared submissions the average was 83 days from receipt to decision (median 44).
Which companies have the most IYB clearances?
Fischer Imaging Corp. (5); Shimadzu Medical Systems (4); Bennett X-Ray Corp. (3); Radkor, Inc. (3); Wuestec Medical, Inc. (2).
Have IYB devices been recalled?
Yes: 13 product recalls across 12 recall events; the most recent began 2025-10-16.
Next steps
- Run an FDA pathway report with predicate devices for product code IYB
- Run a recall and safety report across every IYB manufacturer
- Watch product code IYB 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.