FDA UDI In Commercial Distribution 🇺🇸 United States

QLAB Quantification Software

DI: 00884838070837 · Model: Release 10.7 · Philips Ultrasound, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
QLAB Quantification Software
Primary DI
00884838070837
Version / Model
Release 10.7
Company Name
Philips Ultrasound, Inc.
Labeler DUNS
063377717
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-02-01
Public Version
5
Public Version Date
2023-10-18
Public Version Status
Update
Public Device Record Key
071a4594-4f42-4489-b275-18bd380296dd

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LLZ System, image processing, radiological

GMDN Terms

Code Name
41670 Radiological PACS software

Identifiers

Type ID
Primary 00884838070837