510(k) K924423
K924423 is an FDA 510(k) premarket notification submitted by Midwest X-Ray Equipment Co. for the device "MWX-7440 HIGH SPEED BUCKY". The FDA issued a decision of Substantially Equivalent on January 15, 1993. The device falls under product code KPX (Changer, Radiographic Film/Cassette), a Class II device regulated under 21 CFR 892.1860. Midwest X-Ray Equipment Co. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 1993
- Date Received
- September 1, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Changer, Radiographic Film/Cassette
- Device Class
- Class II
- Regulation Number
- 892.1860
- Review Panel
- RA
- Submission Type