FDA.reportPublic FDA data

Hyland Software, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30085969213008596921Hyland Software, Inc.1N2026-01-0112919 Earhart Avenue Auburn CA US 95602
30087755943008775594HYLAND SOFTWARE, INC.1N2020-04-2528500 Clemens Rd Westlake OH US 44145

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1207391734525873K954875ASPECT ACQUISITION MODULE (AAM)LMA1996-01-02
1238521057043218K101898R4 ACERT ULTRASOUND REPORTING SYSTEMLLZ2011-09-15
1207391355781587K083618PACS SCANLLZ2009-01-28
1207391366660887K042484NAI TECH PRODUCTS MEDICAL DIGITAL RECORDERLMA2004-10-20
1238521715319708K000443REMOTE FETAL MEDICINE ULTRASOUND SYSTEMLLZ2000-04-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ32011-09-15
LMA22004-10-20

GUDID#

NilRead - The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data, including mammography and breast tomosynthesis. NilRead also allows users to collaborate by sharing application sessions. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM “for presentation” images must be used.On mobile platforms, this device is not intended for diagnostic use.

Hyland Software Canada ULC

2020-02-07