ITY · Assembly, Tube Housing, X-Ray, Diagnostic
Radiology · 21 CFR 892.1760 · Class 1
Overview
| Product Code | ITY |
|---|---|
| Device Name | Assembly, Tube Housing, X-Ray, Diagnostic |
| Regulation | 21 CFR 892.1760 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes. This generic type of device may include high voltage and filament transformers or other appropriate components.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.
Cleared Devices (40)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K000052 | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 | Dynarad Corp. | Feb 10, 2000 | SESE |
| K933162 | MRX-750 | Mrx Corp. | Oct 7, 1993 | SESE |
| K923094 | MOLYBDENUM | Southeastern Medical Diagnostics, Inc. | Mar 4, 1993 | SESE |
| K923141 | PHILIPS PRE-FILTER OPTION | Philips Medical Systems, Inc. | Jan 21, 1993 | SESE |
| K921129 | MRX-700 | Mrx-Ray Tube Corp. | Oct 5, 1992 | SESE |
| K921130 | MRX-865 | Mrx-Ray Tube Corp. | Sep 10, 1992 | SESE |
| K921316 | MG-1001 TUBE HOUSING ASSEMBLY | Magma Corp. | Jun 22, 1992 | SESE |
| K920731 | X-RAY TUBE ASSEMBLY CIRCLEX1.2UG | Shimadzu Medical Systems | May 29, 1992 | SESE |
| K920724 | HIGH SPEED ROTATION STARTER SA-50 | Shimadzu Medical Systems | Apr 27, 1992 | SESE |
| K920723 | HIGH SPEED ROTATION STARTER SA-40 | Shimadzu Medical Systems | Apr 27, 1992 | SESE |
| K920387 | CIRCLEXO.3T X-RAY TUBE ASSEMBLY | Shimadzu Medical Systems | Apr 14, 1992 | SESE |
| K913987 | OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID | Codman & Shurtleff, Inc. | Apr 13, 1992 | SESE |
| K913301 | MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM | Comet North America, Inc. | Aug 28, 1991 | SESE |
| K912338 | TUBE HOUSING ASSEMBLIES | Comet Ltd. C/O Radiology Resources, Inc. | Aug 7, 1991 | SESE |
| K911695 | VARIOUS X-RAY TUBES | Comet Ltd. C/O Radiology Resources, Inc. | Jun 19, 1991 | SESE |
| K910308 | X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 | Inmark Corp. | Mar 27, 1991 | SESE |
| K910842 | DI2000/HS-45-150 X-RAY TUBE INSERT | Comet Ltd. C/O Radiology Resources, Inc. | Mar 6, 1991 | SESE |
| K910276 | X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 | Inmark Corp. | Mar 6, 1991 | SESE |
| K904182 | R-800-SF | Advantech | Nov 13, 1990 | SESE |
| K900367 | HOFMANN-NAGEL (HOFNA) X-RAY TUBES | Hofmann | Feb 26, 1990 | SESE |
| K894742 | RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS | Inmark Corp. | Oct 27, 1989 | SESE |
| K894413 | X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS | Inmark Corp. | Sep 22, 1989 | SESE |
| K882939 | NIOBI-X RADIATION REDUCTION FILTER | American Canadian Products, Inc. | Nov 4, 1988 | SESE |
| K882323 | MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000 | Meicor, Inc. | Jun 30, 1988 | SESE |
| K873314 | TOSHIBA, SMIT ROENTGEN | Inland Tube Corp. | Nov 2, 1987 | SESE |
| K871227 | LES RAD FILTER | M. D. Products | Jun 29, 1987 | SESE |
| K870071 | TOSHIBA, SMIT ROENTGEN | North American Imaging, Inc. | Jan 21, 1987 | SESE |
| K864042 | MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH | Absolute X-Ray Corp. | Oct 27, 1986 | SESE |
| K860760 | ERBIUM X-RAY FILTER | Reactor Experiments, Inc. | Jun 10, 1986 | SESE |
| K860504 | 36-101 XDS111 XENON DELIVERY/TRAP SYSTEM | Victoreen, Inc. | Apr 4, 1986 | SESE |
| K840135 | CRISA | X-Ray Tube Corp. | Mar 23, 1984 | SESE |
| K834306 | PHASIX-HIGH FREQUENCY GENERATOR | Cgr Medical Corp. | Dec 29, 1983 | SESE |
| K833847 | CRISA | X-Ray Tube Corp. | Dec 12, 1983 | SESE |
| K833238 | CRISA | X-Ray Tube Corp. | Oct 28, 1983 | SESE |
| K812915 | MX 125 | General Electric Co. | Nov 24, 1981 | SESE |
| K810190 | OPTI 110/12/50HSG | Siemens Corp. | Mar 2, 1981 | SESE |
| K781524 | MAXIRAY 125 TUBE UNIT | General Electric Co. | Oct 17, 1978 | SESE |
| K781540 | OPTI 110/12/50 HSG | Siemens Corp. | Sep 14, 1978 | SESE |
| K770336 | X-RAY TUBE, ROTATING ANODE | Litton Medical Systems | Mar 1, 1977 | SESE |
| K760604 | EUREKA X-SCAN 150 X-RAY TUBE HOUSING AS. | Eureka X-Ray Tube Corp. | Sep 13, 1976 | SESE |
Top Applicants
- Shimadzu Medical Systems — 4 clearances
- Inmark Corp. — 4 clearances
- X-Ray Tube Corp. — 3 clearances
- Comet Ltd. C/O Radiology Resources, Inc. — 3 clearances
- Siemens Corp. — 2 clearances
