Grapefruit USA Inc (GPFT)

[BennyJ]

genoray america - continued
genoray america application took almost 9 to 10 months to get 510k clearance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=31551

Date Received 07/21/2009
Decision Date 04/26/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Statement/Summary/Purged Status Summary only
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No

Original Post
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genoray america - Was trying to figure out how much time genorayamerica took for their volux 510 approval ( similar device 3D image with CT for dental). Couldn't see anywhere when it was first submitted. Seems like recent submission is 2nd, 3rd etc, I do not know.

Don't search for its ticker symbol. not a public company.

Pls see the history here. Volux was originally developed 2008/10
http://www.genorayamerica.com/aboutus-history.htm

But their PR release says as follows:
FDA Approved for VOLUX Dental 3D CT
VOLUX Dental 3D CT have finally received FDA approval!

FOR IMMEDIATE RELEASE

PR Log (Press Release) – Apr 29, 2010 – Orange, CA, USA – 04/28/10 – Genoray America Inc. of Orange, CA has announced that their VOLUX, Dental 3D CT device has acquired FDA approval.
This delayed approval opens a new door to Genoray America Inc. as they are now entering prominent field of 3D Dental Imaging. Genoray America Inc. claims their cone-beam CT is sure to make noticeable shift in dental market. Genoray America Inc., a professional x-ray manufacturer which have sold over 1,000 of their C-Arms worldwide since 2001 will be at upcoming CDA Anaheim show from May 14 ~ 16 at booth # 563.

Genoray America Inc.
1073 N. Batavia St., Orange, CA 92867
Jae Kim; Manager of Marketing & Communications
(T) 714-289-8020 (F) 714-453-9661
www.genorayamerica.com

It seems like it has been resubmitted few times and finally got an approval.
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092171.pdf
FDA didn't follow their 30 days guideline though. see the received & FDA stamp date on clearance.

Checked couple of other 510 k clearance on April. Some of them have been cleared(not complex devices) and received responses within 30 days, some passed 30 days time frame, saw one passing the 45 days time frame.

So it is not the norm or rule for 30 days response. varies device to device. Hopefully tomorrow or before this weekend.

Dr. Polk from the other board blatantly saying that last informal request/response from IMGG to FDA on 23rd April as a same day request - (2 sentence changes and format changes). Don't know how far we can belive Dr. Polk's statement.

April approval list:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm210975.htm

Hope for the best & cheers.