MX 125
FDA 510(k) clearance K812915 · decided 1981-11-24
Clearance details
- K-number
- K812915
- Device name
- MX 125
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1981-10-19
- Decision date
- 1981-11-24
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- ITY
- Device class
- 1
- Regulation number
- 892.1760
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 (K000052) | Dynarad Corp. | 2000-02-10 |
| MRX-750 (K933162) | Mrx Corp. | 1993-10-07 |
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| 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 |
| X-RAY TUBE ASSEMBLY CIRCLEX1.2UG (K920731) | Shimadzu Medical Systems | 1992-05-29 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017) | General Electric Co. | 1988-07-29 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013) | General Electric Co. | 1988-07-15 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016) | General Electric Co. | 1988-06-30 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S014) | General Electric Co. | 1988-05-05 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S015) | General Electric Co. | 1988-05-02 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012) | General Electric Co. | 1987-11-25 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S011) | General Electric Co. | 1987-06-18 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S010) | General Electric Co. | 1987-03-30 |