Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K153492
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K153492
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
A2-201/B3-501, BIOBAY, 218 XINGHU STREET,
SUZHOU INDUSTRIAL PARK
SUZHOU 215123 CN
Other 510(k) Applications for this Company
Contact
Leilei Li
Other 510(k) Applications for this Contact
Regulation Number
892.1650
More FDA Info for this Regulation Number
Classification Product Code
MQB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/04/2015
Decision Date
12/24/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact