SUPERMAX AUTOMATIC X-RAY PROCESSOR
FDA 510(k) clearance K760905 · decided 1976-11-19
Clearance details
- K-number
- K760905
- Device name
- SUPERMAX AUTOMATIC X-RAY PROCESSOR
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1976-10-26
- Decision date
- 1976-11-19
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- IXW
- Device class
- 2
- Regulation number
- 892.1900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 (K023613) | Alphatek Corp. | 2003-01-23 |
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| MICRO-MAX, MODEL 319 (K002404) | Tek Marketing, Inc. | 2000-08-30 |
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| OPTIMAX/ COMPACT 2 (K992818) | Protec GmbH & Co. KG | 1999-09-01 |
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 |