SPOT-FILM DEVICE 8835
FDA 510(k) clearance K842184 · decided 1984-07-17
Clearance details
- K-number
- K842184
- Device name
- SPOT-FILM DEVICE 8835
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-01
- Decision date
- 1984-07-17
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- IXL
- Device class
- 2
- Regulation number
- 892.1670
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| OPTIMA XR120 (K111304) | Ge Medical Systems, LLC | 2011-07-19 |
| MD-1835 (K964806) | Fischer Imaging Corp. | 1997-03-04 |
| ADVANTX 1824 SPOTFILM DEVICE (K950317) | GE Medical Systems | 1995-02-08 |
| KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP (K940386) | Eastman Kodak Company | 1994-08-17 |
| AXT 1400 SPOTFILM DEVICE (K942367) | Applied X-Ray Technologies, Inc. | 1994-06-06 |
| DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 (K924593) | Philips Medical Systems, Inc. | 1992-11-24 |
| ELITE R/F SPOT FILM DRIVE (K902403) | Rms Div. | 1990-08-01 |
| SFD-035 SPOT FILM DEVICE (K902146) | Rms Div. | 1990-05-31 |
| A.X.T. SPOTFILM DEVICE (K882492) | Applied X-Ray Technologies, Inc. | 1988-07-21 |
| 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 (K881589) | Continental X-Ray Corp. | 1988-07-18 |
| RAYTHEON MEDICAL IMAGING (K802888) | Machlett Laboratories, Inc. | 1981-01-09 |
| MULTI-FORMAT SFD MODEL 1720 (K800554) | Philips Medical Systems (Cleveland), Inc. | 1980-04-10 |
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 |