510(k) K052447
K052447 is an FDA 510(k) premarket notification submitted by Analogic Corp. for the device "SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600". The FDA issued a decision of Substantially Equivalent on Sep 21, 2005. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Analogic Corp. has 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 2005
- Date Received
- Sep 7, 2005
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)