FDA product code IXY: Holder, Radiographic Cassette, Wall-Mounted
IXY is the FDA product code for holder, radiographic cassette, wall-mounted. It is a Class I device, regulated under 21 CFR 892.1880 and reviewed by the Radiology panel. FDA has cleared 21 510(k) submissions under IXY, from 18 different applicants. The average 510(k) review took 72 days (median 56). FDA has posted 5 recalls for IXY devices.
Classification
| Field | Value |
|---|---|
| Device name | Holder, Radiographic Cassette, Wall-Mounted |
| Device class | Class I |
| Regulation | 21 CFR 892.1880 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IXY clearance
Top IXY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Philips Medical Systems (Cleveland), Inc. | 4 | 1995-08-11 |
| Cmed | 1 | 1995-04-28 |
| Scott Imaging Intl., Inc. | 1 | 1995-03-31 |
| American Medical Sales, Inc. | 1 | 1993-04-27 |
| Tingle X-Ray Products, Inc. | 1 | 1993-04-27 |
13 more applicants have IXY clearances. See the full list in Caduvo.
Most recent IXY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K953336 | Philips Medical Systems (Cleveland), Inc. | VRS 3 WALL STAND | 1995-08-11 | 25 |
| K953402 | Philips Medical Systems (Cleveland), Inc. | UNIVERSIX 190 | 1995-08-11 | 22 |
| K946114 | Cmed | SENSORI-MOTOR RATING SCALE | 1995-04-28 | 134 |
| K946260 | Scott Imaging Intl., Inc. | NTBS-1417, 1436, TBS-1417 | 1995-03-31 | 108 |
| K930230 | American Medical Sales, Inc. | RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER | 1993-04-27 | 98 |
Recalls for IXY devices
5 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-11-08.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code IXY?
IXY is the FDA product code for holder, radiographic cassette, wall-mounted. It is a Class I device, regulated under 21 CFR 892.1880 and reviewed by the Radiology panel.
What device class is IXY?
Class I, regulation 21 CFR 892.1880. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IXY?
Across 21 cleared submissions the average was 72 days from receipt to decision (median 56).
Which companies have the most IXY clearances?
Philips Medical Systems (Cleveland), Inc. (4); Cmed (1); Scott Imaging Intl., Inc. (1); American Medical Sales, Inc. (1); Tingle X-Ray Products, Inc. (1).
Have IXY devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2018-11-08.
Next steps
- Run an FDA pathway report with predicate devices for product code IXY
- Run a recall and safety report across every IXY manufacturer
- Watch product code IXY 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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