510(k) K860454
K860454 is an FDA 510(k) premarket notification submitted by Siemens Gammasonics, Inc. for the device "BASICAM S COUNTER BALANCE CAMERA". The FDA issued a decision of Substantially Equivalent on February 21, 1986. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. Siemens Gammasonics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1986
- Date Received
- February 5, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Radiographic Cassette, Wall-Mounted
- Device Class
- Class I
- Regulation Number
- 892.1880
- Review Panel
- RA
- Submission Type