PowerLook AMP SLD Planmed

GUDID 00858012005168

Icad, Inc.

Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software
Primary Device ID00858012005168
NIH Device Record Key0e00fc38-458b-4455-bd07-11ae43426002
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerLook AMP SLD Planmed
Version Model NumberDSC010-08
Company DUNS108870254
Company NameIcad, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858012005168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYNAnalyzer, Medical Image

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-25
Device Publish Date2021-05-17

Devices Manufactured by Icad, Inc.

00850008977527 - PowerLook 11.32023-08-10
00085000897751 - PowerLook Cloud 1.0 2023-07-25
00850008977442 - PowerLook 11.2 2023-07-24
00850008977459 - PowerLook Al Mammo Container - Radiology Partners v1.0.0 2023-07-24
00850008977466 - PowerLook Al Mammo Container- GE v1.1.0 2023-07-24
00850008977473 - PowerLook Al Mammo Container- Blackford v1.0.0 2023-07-24
00850008977480 - PowerLook Al Mammo Container- Ferrum v1.0.0 2023-07-24
00850008977497 - PowerLook Al Mammo Container - Arterys v 1.2.02023-07-24

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