MAXICAMERA 400T W/BODY CONTOUR TOMOGRA
FDA 510(k) clearance K841996 · decided 1984-07-16
Clearance details
- K-number
- K841996
- Device name
- MAXICAMERA 400T W/BODY CONTOUR TOMOGRA
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-05-16
- Decision date
- 1984-07-16
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- JAM
- Device class
- 1
- Regulation number
- 892.1330
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Walker, MI, 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 |
|---|---|---|
| WBA - I.R.I.S. (K842895) | Siemens Gammasonics, Inc. | 1984-08-27 |
| CLEON IMAGER (K770530) | Union Carbide Corp. | 1977-04-05 |
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 |