Assembly, Tube Housing, X-Ray, Diagnostic
Regulation 892.1760
0510(k)s in 12 months (40 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in ITY
| Company | 510(k)s | Recalls |
|---|---|---|
| Inmark Corp. | 4 | 0 |
| Shimadzu Medical Systems | 4 | 0 |
| Comet Ltd. C/O Radiology Resources, Inc. | 3 | 0 |
| Dunlee | 0 | 3 |
| X-Ray Tube Corp. | 3 | 0 |
| General Electric Co. | 2 | 0 |
| Mrx-Ray Tube Corp. | 2 | 0 |
| Siemens Corp. | 2 | 0 |
| Absolute X-Ray Corp. | 1 | 0 |
| Advantech | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 10, 2000 | K000052 | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 Dynarad Corp. | ITY |
| Oct 7, 1993 | K933162 | MRX-750 Mrx Corp. | ITY |
| Mar 4, 1993 | K923094 | MOLYBDENUM Southeastern Medical Diagnostics, Inc. | ITY |
| Jan 21, 1993 | K923141 | PHILIPS PRE-FILTER OPTION Philips Medical Systems, Inc., NL | ITY |
| Oct 5, 1992 | K921129 | MRX-700 Mrx-Ray Tube Corp. | ITY |
| Sep 10, 1992 | K921130 | MRX-865 Mrx-Ray Tube Corp. | ITY |
| Jun 22, 1992 | K921316 | MG-1001 TUBE HOUSING ASSEMBLY Magma Corp. | ITY |
| May 29, 1992 | K920731 | X-RAY TUBE ASSEMBLY CIRCLEX1.2UG Shimadzu Medical Systems | ITY |
| Apr 27, 1992 | K920724 | HIGH SPEED ROTATION STARTER SA-50 Shimadzu Medical Systems | ITY |
| Apr 27, 1992 | K920723 | HIGH SPEED ROTATION STARTER SA-40 Shimadzu Medical Systems | ITY |
| Apr 14, 1992 | K920387 | CIRCLEXO.3T X-RAY TUBE ASSEMBLY Shimadzu Medical Systems | ITY |
| Apr 13, 1992 | K913987 | OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID Codman & Shurtleff, Inc. | ITY |
| Aug 28, 1991 | K913301 | MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM Comet North America, Inc. | ITY |
| Aug 7, 1991 | K912338 | TUBE HOUSING ASSEMBLIES Comet Ltd. C/O Radiology Resources, Inc., CH | ITY |
| Jun 19, 1991 | K911695 | VARIOUS X-RAY TUBES Comet Ltd. C/O Radiology Resources, Inc., CH | ITY |
| Mar 27, 1991 | K910308 | X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 Inmark Corp. | ITY |
| Mar 6, 1991 | K910842 | DI2000/HS-45-150 X-RAY TUBE INSERT Comet Ltd. C/O Radiology Resources, Inc., CH | ITY |
| Mar 6, 1991 | K910276 | X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 Inmark Corp. | ITY |
| Nov 13, 1990 | K904182 | R-800-SF Advantech | ITY |
| Feb 26, 1990 | K900367 | HOFMANN-NAGEL (HOFNA) X-RAY TUBES Hofmann | ITY |
| Oct 27, 1989 | K894742 | RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS Inmark Corp. | ITY |
| Sep 22, 1989 | K894413 | X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS Inmark Corp. | ITY |
| Nov 4, 1988 | K882939 | NIOBI-X RADIATION REDUCTION FILTER American Canadian Products, Inc. | ITY |
| Jun 30, 1988 | K882323 | MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000 Meicor, Inc. | ITY |
| Nov 2, 1987 | K873314 | TOSHIBA, SMIT ROENTGEN Inland Tube Corp. | ITY |
| Jun 29, 1987 | K871227 | LES RAD FILTER M. D. Products | ITY |
| Jan 21, 1987 | K870071 | TOSHIBA, SMIT ROENTGEN North American Imaging, Inc. | ITY |
| Oct 27, 1986 | K864042 | MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH Absolute X-Ray Corp. | ITY |
| Jun 10, 1986 | K860760 | ERBIUM X-RAY FILTER Reactor Experiments, Inc. | ITY |
| Apr 4, 1986 | K860504 | 36-101 XDS111 XENON DELIVERY/TRAP SYSTEM Victoreen, Inc. | ITY |
| Mar 23, 1984 | K840135 | CRISA X-Ray Tube Corp. | ITY |
| Dec 29, 1983 | K834306 | PHASIX-HIGH FREQUENCY GENERATOR Cgr Medical Corp. | ITY |
| Dec 12, 1983 | K833847 | CRISA X-Ray Tube Corp. | ITY |
| Oct 28, 1983 | K833238 | CRISA X-Ray Tube Corp. | ITY |
| Nov 24, 1981 | K812915 | MX 125 General Electric Co. | ITY |
| Mar 2, 1981 | K810190 | OPTI 110/12/50HSG Siemens Corp. | ITY |
| Oct 17, 1978 | K781524 | MAXIRAY 125 TUBE UNIT General Electric Co. | ITY |
| Sep 14, 1978 | K781540 | OPTI 110/12/50 HSG Siemens Corp. | ITY |
| Mar 1, 1977 | K770336 | X-RAY TUBE, ROTATING ANODE Litton Medical Systems | ITY |
| Sep 13, 1976 | K760604 | EUREKA X-SCAN 150 X-RAY TUBE HOUSING AS. Eureka X-Ray Tube Corp. | ITY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.