X-RAY TUBE ASSEMBLY CIRCLEX1.2UG
FDA 510(k) clearance K920731 · decided 1992-05-29
Clearance details
- K-number
- K920731
- Device name
- X-RAY TUBE ASSEMBLY CIRCLEX1.2UG
- Applicant
- Shimadzu Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1992-02-18
- Decision date
- 1992-05-29
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- ITY
- Device class
- 1
- Regulation number
- 892.1760
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Gardena, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 (K000052) | Dynarad Corp. | 2000-02-10 |
| MRX-750 (K933162) | Mrx Corp. | 1993-10-07 |
| MOLYBDENUM (K923094) | Southeastern Medical Diagnostics, Inc. | 1993-03-04 |
| PHILIPS PRE-FILTER OPTION (K923141) | Philips Medical Systems, Inc. | 1993-01-21 |
| MRX-700 (K921129) | Mrx-Ray Tube Corp. | 1992-10-05 |
| MRX-865 (K921130) | Mrx-Ray Tube Corp. | 1992-09-10 |
| MG-1001 TUBE HOUSING ASSEMBLY (K921316) | Magma Corp. | 1992-06-22 |
| HIGH SPEED ROTATION STARTER SA-50 (K920724) | Shimadzu Medical Systems | 1992-04-27 |
| HIGH SPEED ROTATION STARTER SA-40 (K920723) | Shimadzu Medical Systems | 1992-04-27 |
| CIRCLEXO.3T X-RAY TUBE ASSEMBLY (K920387) | Shimadzu Medical Systems | 1992-04-14 |
| OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID (K913987) | Codman & Shurtleff, Inc. | 1992-04-13 |
| MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM (K913301) | Comet North America, Inc. | 1991-08-28 |
Recalls involving this device
No recalls on record reference this clearance.