Grapefruit USA Inc (GPFT)

[BennyJ]

Medtronic o-arm imaging system
This is an upgrade in their existing system. The submission type is "ABBREVIATED" which normally takes less time than "TRADITIONAL" since there is an already their own 510k approved predicate device available. See the received date

My point here is that "THE LAST REVIEW TEAM DID NOT DO THE GOOD JOB". It took, HECK! 10 months to get the approval. When the new team/device head took over(I believe in Januray this year), they start approving long pending delays as you can see here. I can't wait to hear the approval news of Dominion DVIS!

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=31850
Some board member already posted Dean's comment about this comparing DVIS, price(2X of DVIS price) and other disadvantages of o-arm when starting from still state. Let me scan thru that post, if I find, I will repost.

Device Classification Name system, x-ray, mobile
510(k) Number K092564
Device Name O-ARM IMAGING SYSTEM
Applicant MEDTRONIC NAVIGATION, INC. (LITTLETON)
300 foster street
littleton, MA 01460

Contact seth kuzdzal
Regulation Number 892.1720
Classification Product Code IZL

Subsequent Product Code LHN

Date Received 08/20/2009
Decision Date 06/17/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Statement/Summary/Purged Status Summary only
Type Abbreviated
Reviewed by Third Party No
Expedited Review No