SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM
Device Facts
| Record ID | K885127 |
|---|---|
| Device Name | SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM |
| Applicant | Fischer Imaging Corp. |
| Product Code | LMC · Radiology |
| Decision Date | Feb 16, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2040 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
