ITY — Assembly, Tube Housing, X-Ray, Diagnostic Class I
FDA product code ITY covers "Assembly, Tube Housing, X-Ray, Diagnostic", a Class I medical device regulated under 21 CFR 892.1760. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ITY
- Device Class
- Class I
- Regulation Number
- 892.1760
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K000052 | Dynarad | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 | Feb 10, 2000 |
| K933162 | Mrx | MRX-750 | Oct 7, 1993 |
| K923094 | Southeastern Medical Diagnostics | MOLYBDENUM | Mar 4, 1993 |
| K923141 | Philips Medical Systems | PHILIPS PRE-FILTER OPTION | Jan 21, 1993 |
| K921129 | Mrx-Ray Tube | MRX-700 | Oct 5, 1992 |
| K921130 | Mrx-Ray Tube | MRX-865 | Sep 10, 1992 |
| K921316 | Magma | MG-1001 TUBE HOUSING ASSEMBLY | Jun 22, 1992 |
| K920731 | Shimadzu Medical Systems | X-RAY TUBE ASSEMBLY CIRCLEX1.2UG | May 29, 1992 |
| K920723 | Shimadzu Medical Systems | HIGH SPEED ROTATION STARTER SA-40 | Apr 27, 1992 |
| K920724 | Shimadzu Medical Systems | HIGH SPEED ROTATION STARTER SA-50 | Apr 27, 1992 |
| K920387 | Shimadzu Medical Systems | CIRCLEXO.3T X-RAY TUBE ASSEMBLY | Apr 14, 1992 |
| K913987 | Codman And Shurtleff | OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID | Apr 13, 1992 |
| K913301 | Comet North America | MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM | Aug 28, 1991 |
| K912338 | Comet Ltd. C/O Radiology Resources | TUBE HOUSING ASSEMBLIES | Aug 7, 1991 |
| K911695 | Comet Ltd. C/O Radiology Resources | VARIOUS X-RAY TUBES | Jun 19, 1991 |
| K910308 | Inmark | X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 | Mar 27, 1991 |
| K910842 | Comet Ltd. C/O Radiology Resources | DI2000/HS-45-150 X-RAY TUBE INSERT | Mar 6, 1991 |
| K910276 | Inmark | X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 | Mar 6, 1991 |
| K904182 | Advantech | R-800-SF | Nov 13, 1990 |
| K900367 | Hofmann | HOFMANN-NAGEL (HOFNA) X-RAY TUBES | Feb 26, 1990 |