PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM
FDA 510(k) clearance K872245 · decided 1987-06-19
Clearance details
- K-number
- K872245
- Device name
- PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-11
- Decision date
- 1987-06-19
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- IXC
- Device class
- 1
- Regulation number
- 892.1890
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, 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 |
|---|---|---|
| SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS (K991302) | Smartlight, Inc. | 1999-06-01 |
| SMART MOTORIZED VIEWER (K973965) | Smartlight, Ltd. | 1997-12-12 |
| ARRIPRO 35 ST/TV (K973115) | Arnold & Richter Cine Technik | 1997-09-02 |
| DIFFUSER PANEL (K970240) | Focused Viewer, Inc. | 1997-03-11 |
| LILY DARK VIEWER (K954998) | Lily Imaging Solutions Co. | 1996-01-29 |
| VOXBOX (K954199) | Voxel | 1995-09-29 |
| ADVIEWER 2000 (K952188) | Adp , Ltd. | 1995-05-30 |
| ULTRALITE X-RAY FILM ILLUMINATOR (K922848) | A & S Trading Co. | 1992-09-28 |
| ROTOLUX, SELECTOLUX, SHUTTERVUE (K922079) | American Medical Sales, Inc. | 1992-06-16 |
| EXCELVIEW ILLUMINATOR (K883702) | Excel Medical Products, Inc. | 1988-09-19 |
| VARIVIEWER (X-RAY FILM VIEWER) (K875233) | Diversified Diagnostic Products, Inc. | 1988-01-19 |
| SANDHILL ELECTRONIC CALIPER (K854933) | Sandhill | 1986-02-12 |
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 |