FDA Product Code
FDA Product Code ITY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1760
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K000052 | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 | Dynarad Corp. | 2000-02-10 | Traditional | PDF ↗ |
| K933162 | MRX-750 | Mrx Corp. | 1993-10-07 | Traditional | PDF ↗ |
| K923094 | MOLYBDENUM | Southeastern Medical Diagnostics, Inc. | 1993-03-04 | Traditional | PDF ↗ |
| K923141 | PHILIPS PRE-FILTER OPTION | Philips Medical Systems, Inc. | 1993-01-21 | Traditional | PDF ↗ |
| K921129 | MRX-700 | Mrx-Ray Tube Corp. | 1992-10-05 | Traditional | PDF ↗ |
| K921130 | MRX-865 | Mrx-Ray Tube Corp. | 1992-09-10 | Traditional | PDF ↗ |
| K921316 | MG-1001 TUBE HOUSING ASSEMBLY | Magma Corp. | 1992-06-22 | Traditional | PDF ↗ |
| K920731 | X-RAY TUBE ASSEMBLY CIRCLEX1.2UG | Shimadzu Medical Systems | 1992-05-29 | Traditional | PDF ↗ |
| K920723 | HIGH SPEED ROTATION STARTER SA-40 | Shimadzu Medical Systems | 1992-04-27 | Traditional | PDF ↗ |
| K920724 | HIGH SPEED ROTATION STARTER SA-50 | Shimadzu Medical Systems | 1992-04-27 | Traditional | PDF ↗ |
| K920387 | CIRCLEXO.3T X-RAY TUBE ASSEMBLY | Shimadzu Medical Systems | 1992-04-14 | Traditional | PDF ↗ |
| K913987 | OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID | Codman & Shurtleff, Inc. | 1992-04-13 | Traditional | PDF ↗ |
| K913301 | MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM | Comet North America, Inc. | 1991-08-28 | Traditional | PDF ↗ |
| K912338 | TUBE HOUSING ASSEMBLIES | Comet Ltd. C/O Radiology Resources, Inc. | 1991-08-07 | Traditional | PDF ↗ |
| K911695 | VARIOUS X-RAY TUBES | Comet Ltd. C/O Radiology Resources, Inc. | 1991-06-19 | Traditional | PDF ↗ |
| K910308 | X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 | Inmark Corp. | 1991-03-27 | Traditional | PDF ↗ |
| K910842 | DI2000/HS-45-150 X-RAY TUBE INSERT | Comet Ltd. C/O Radiology Resources, Inc. | 1991-03-06 | Traditional | PDF ↗ |
| K910276 | X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 | Inmark Corp. | 1991-03-06 | Traditional | PDF ↗ |
| K904182 | R-800-SF | Advantech | 1990-11-13 | Traditional | PDF ↗ |
| K900367 | HOFMANN-NAGEL (HOFNA) X-RAY TUBES | Hofmann | 1990-02-26 | Traditional | PDF ↗ |
| K894742 | RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS | Inmark Corp. | 1989-10-27 | Traditional | PDF ↗ |
| K894413 | X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS | Inmark Corp. | 1989-09-22 | Traditional | PDF ↗ |
| K882939 | NIOBI-X RADIATION REDUCTION FILTER | American Canadian Products, Inc. | 1988-11-04 | Traditional | PDF ↗ |
| K882323 | MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000 | Meicor, Inc. | 1988-06-30 | Traditional | PDF ↗ |
| K873314 | TOSHIBA, SMIT ROENTGEN | Inland Tube Corp. | 1987-11-02 | Traditional | PDF ↗ |
| K871227 | LES RAD FILTER | M. D. Products | 1987-06-29 | Traditional | PDF ↗ |
| K870071 | TOSHIBA, SMIT ROENTGEN | North American Imaging, Inc. | 1987-01-21 | Traditional | PDF ↗ |
| K864042 | MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH | Absolute X-Ray Corp. | 1986-10-27 | Traditional | PDF ↗ |
| K860760 | ERBIUM X-RAY FILTER | Reactor Experiments, Inc. | 1986-06-10 | Traditional | PDF ↗ |
| K860504 | 36-101 XDS111 XENON DELIVERY/TRAP SYSTEM | Victoreen, Inc. | 1986-04-04 | Traditional | PDF ↗ |
| K840135 | CRISA | X-Ray Tube Corp. | 1984-03-23 | Traditional | PDF ↗ |
| K834306 | PHASIX-HIGH FREQUENCY GENERATOR | Cgr Medical Corp. | 1983-12-29 | Traditional | PDF ↗ |
| K833847 | CRISA | X-Ray Tube Corp. | 1983-12-12 | Traditional | PDF ↗ |
| K833238 | CRISA | X-Ray Tube Corp. | 1983-10-28 | Traditional | PDF ↗ |
| K812915 | MX 125 | General Electric Co. | 1981-11-24 | Traditional | PDF ↗ |
| K810190 | OPTI 110/12/50HSG | Siemens Corp. | 1981-03-02 | Traditional | PDF ↗ |
| K781524 | MAXIRAY 125 TUBE UNIT | General Electric Co. | 1978-10-17 | Traditional | PDF ↗ |
| K781540 | OPTI 110/12/50 HSG | Siemens Corp. | 1978-09-14 | Traditional | PDF ↗ |
| K770336 | X-RAY TUBE, ROTATING ANODE | Litton Medical Systems | 1977-03-01 | Traditional | PDF ↗ |
| K760604 | EUREKA X-SCAN 150 X-RAY TUBE HOUSING AS. | Eureka X-Ray Tube Corp. | 1976-09-13 | Traditional | PDF ↗ |
Product code ITY · Class I · Radiology. Data: openFDA.