510(k) K992467
K992467 is an FDA 510(k) premarket notification submitted by Dba Systems, Inc. for the device "IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM". The FDA issued a decision of Substantially Equivalent on February 10, 2000. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Dba Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2000
- Date Received
- July 23, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digitizer, Image, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2030
- Review Panel
- RA
- Submission Type