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 | February 10, 2000 |
| K933162 | mrx | MRX-750 | October 7, 1993 |
| K923094 | southeastern medical diagnostics | MOLYBDENUM | March 4, 1993 |
| K923141 | philips medical systems | PHILIPS PRE-FILTER OPTION | January 21, 1993 |
| K921129 | mrx-ray tube | MRX-700 | October 5, 1992 |
| K921130 | mrx-ray tube | MRX-865 | September 10, 1992 |
| K921316 | magma | MG-1001 TUBE HOUSING ASSEMBLY | June 22, 1992 |
| K920731 | shimadzu medical systems | X-RAY TUBE ASSEMBLY CIRCLEX1.2UG | May 29, 1992 |
| K920724 | shimadzu medical systems | HIGH SPEED ROTATION STARTER SA-50 | April 27, 1992 |
| K920723 | shimadzu medical systems | HIGH SPEED ROTATION STARTER SA-40 | April 27, 1992 |
| K920387 | shimadzu medical systems | CIRCLEXO.3T X-RAY TUBE ASSEMBLY | April 14, 1992 |
| K913987 | codman and shurtleff | OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID | April 13, 1992 |
| K913301 | comet north america | MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM | August 28, 1991 |
| K912338 | comet ltd. c/o radiology resources | TUBE HOUSING ASSEMBLIES | August 7, 1991 |
| K911695 | comet ltd. c/o radiology resources | VARIOUS X-RAY TUBES | June 19, 1991 |
| K910308 | inmark | X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 | March 27, 1991 |
| K910276 | inmark | X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 | March 6, 1991 |
| K910842 | comet ltd. c/o radiology resources | DI2000/HS-45-150 X-RAY TUBE INSERT | March 6, 1991 |
| K904182 | advantech | R-800-SF | November 13, 1990 |
| K900367 | hofmann | HOFMANN-NAGEL (HOFNA) X-RAY TUBES | February 26, 1990 |