FDA product code ITY: Assembly, Tube Housing, X-Ray, Diagnostic
ITY is the FDA product code for assembly, tube housing, x-ray, diagnostic. It is a Class I device, regulated under 21 CFR 892.1760 and reviewed by the Radiology panel. FDA has cleared 40 510(k) submissions under ITY, from 27 different applicants. The average 510(k) review took 76 days (median 66). FDA has posted 4 recalls for ITY devices.
Classification
| Field | Value |
|---|---|
| Device name | Assembly, Tube Housing, X-Ray, Diagnostic |
| Device class | Class I |
| Regulation | 21 CFR 892.1760 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every ITY clearance
Top ITY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shimadzu Medical Systems | 4 | 1992-05-29 |
| Inmark Corp. | 4 | 1991-03-27 |
| Comet Ltd. C/O Radiology Resources, Inc. | 3 | 1991-08-07 |
| X-Ray Tube Corp. | 3 | 1984-03-23 |
| Mrx-Ray Tube Corp. | 2 | 1992-10-05 |
22 more applicants have ITY clearances. See the full list in Caduvo.
Most recent ITY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K000052 | Dynarad Corp. | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 | 2000-02-10 | 34 |
| K933162 | Mrx Corp. | MRX-750 | 1993-10-07 | 100 |
| K923094 | Southeastern Medical Diagnostics, Inc. | MOLYBDENUM | 1993-03-04 | 252 |
| K923141 | Philips Medical Systems, Inc. | PHILIPS PRE-FILTER OPTION | 1993-01-21 | 206 |
| K921129 | Mrx-Ray Tube Corp. | MRX-700 | 1992-10-05 | 209 |
Recalls for ITY devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-04-07.
Frequently asked questions
What is FDA product code ITY?
ITY is the FDA product code for assembly, tube housing, x-ray, diagnostic. It is a Class I device, regulated under 21 CFR 892.1760 and reviewed by the Radiology panel.
What device class is ITY?
Class I, regulation 21 CFR 892.1760. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ITY?
Across 40 cleared submissions the average was 76 days from receipt to decision (median 66).
Which companies have the most ITY clearances?
Shimadzu Medical Systems (4); Inmark Corp. (4); Comet Ltd. C/O Radiology Resources, Inc. (3); X-Ray Tube Corp. (3); Mrx-Ray Tube Corp. (2).
Have ITY devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2005-04-07.
Next steps
- Run an FDA pathway report with predicate devices for product code ITY
- Run a recall and safety report across every ITY manufacturer
- Watch product code ITY 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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