510(k) K945452
K945452 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "UD 150L-F". The FDA issued a decision of Substantially Equivalent on March 21, 1995. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Shimadzu Medical Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1995
- Date Received
- November 7, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, High-Voltage, X-Ray, Diagnostic
- Device Class
- Class I
- Regulation Number
- 892.1700
- Review Panel
- RA
- Submission Type