Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K150415 |
Device Name |
NilRead |
Applicant |
Perceptive Software |
120 Carlton St., Suite 217 |
Toronto,
CA
M5A 4K2
|
|
Applicant Contact |
Claudio Gatti |
Correspondent |
Perceptive Software |
120 Carlton St., Suite 217 |
Toronto,
CA
M5A 4K2
|
|
Correspondent Contact |
Sandra Stapleton |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 02/18/2015 |
Decision Date | 06/12/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|