510(k) K924459
K924459 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "DIGISCAN 2". The FDA issued a decision of Substantially Equivalent on December 17, 1992. The device falls under product code IXK (System, Imaging, X-Ray, Electrostatic), a Class II device regulated under 21 CFR 892.1630. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1992
- Date Received
- September 2, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, X-Ray, Electrostatic
- Device Class
- Class II
- Regulation Number
- 892.1630
- Review Panel
- RA
- Submission Type