Grapefruit USA Inc (GPFT)

[hubris heyday]

BennyJ I was reading over your post #19663 and I agree a simple upgrade took 10 months but see below.. I think the third party review helped them a bit. The received date shows it was less than a month for a FDA decision. Maybe Breakaway Imaging had submitted over a length of time as IMGG has done but the third party review just did it for them. Anyway The O arm was found substantially equivalent to the Siemens SIREMOBIL. Is the Dvis substantially equivalent to the O arm????

Sorry in advance if we have talked about this third party review before... I have read so much crapola i cant remember..

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=18110

Device Classification Name System, X-Ray, Mobile
510(K) Number K050996
Device Name O-ARM IMAGING SYSTEM
Applicant
BREAKAWAY IMAGING, LLC
300 Foster Street
Littleton, MA 01460
Contact Wolfgang Krull
Regulation Number 892.1720
Classification Product Code
IZL
Date Received 04/20/2005
Decision Date 05/05/2005
Decision Substantially Equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Statement/Summary/Purged Status Summary Only
Summary Summary
Type Abbreviated
Reviewed By Third Party Yes
Expedited Review No