K970628 is an FDA 510(k) clearance for the GE ADVANTAGE DIGITIZER WORKSTATION. This device is classified as a System, Digital Image Communications, Radiological (Class I - General Controls, product code LMD).
Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on May 12, 1997, 82 days after receiving the submission on February 19, 1997.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2020. A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. It May Provide Simple Image Review Software Functionality For Medical Image Processing And Manipulation, Such As Grayscale Window And Level, Zoom And Pan, User Delineated Geometric Measurements, Compression, Or User Added Image Annotations. The Device Does Not Perform Advanced Image Processing Or Complex Quantitative Functions..
| 510(k) Number | K970628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1997 |
| Decision Date | May 12, 1997 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LMD - System, Digital Image Communications, Radiological |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.2020 |
| Definition | A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. It May Provide Simple Image Review Software Functionality For Medical Image Processing And Manipulation, Such As Grayscale Window And Level, Zoom And Pan, User Delineated Geometric Measurements, Compression, Or User Added Image Annotations. The Device Does Not Perform Advanced Image Processing Or Complex Quantitative Functions. |