• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceIMAGECHECKER M1000 PROCESSOR WITH V1.3 RELEASE
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
Applicant
HOLOGIC, INC.
35 crosby dr.
bedford, MA 01730
PMA NumberP970058
Supplement NumberS001
Date Received09/29/1998
Decision Date10/21/1998
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design changes that relocate the scsi, support a new paper printer, correct several minor bugs and add minor operational enhancements.
-
-