Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K173780
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K173780
Device Name
System, Image Processing, Radiological
Applicant
Bay Labs, Inc.
290 King Street
San Francisco, CA 94107 US
Other 510(k) Applications for this Company
Contact
Charles Cadieu
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/12/2017
Decision Date
06/14/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact