510(k) K780995
K780995 is an FDA 510(k) premarket notification submitted by Emi Medical, Inc. for the device "COMPUTERIZED AXIAL TOMOGRAPHY". The FDA issued a decision of Substantially Equivalent on June 22, 1978. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Emi Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 1978
- Date Received
- June 14, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomographic
- Device Class
- Class II
- Regulation Number
- 892.1740
- Review Panel
- RA
- Submission Type