DynaLOC Breast Interventional Planning Software D75014-05, D57015-05

GUDID 00858012005779

The DynaLOC Breast Interventional Planning software module supports the use of MR interventional breast coils and localization devices to perform MR-guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion, relative to the interventional device. The accuracy of DynaLOC software depends on the resolution of the acquired dataset. If the sum of the slice thicknesses for marker and target series does not exceed 5 mm, the 3-dimensional accuracy is 5 mm. Otherwise it is equal to the sum of two slice thicknesses for marker and target series. The accuracy can be negatively affected by any of the following: • Significant patient movement after the breast is securely immobilized in the biopsy device • Significant displacement of tissue during needle penetration • Image distortion in the MR dataset.

Icad, Inc.

Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software
Primary Device ID00858012005779
NIH Device Record Keyad9d710e-5971-4416-bfe0-2f60b5941a99
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaLOC Breast Interventional Planning Software
Version Model Number3.5
Catalog NumberD75014-05, D57015-05
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com
Phone1-866-280-2239
Emailsupport@icadmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858012005779 [Primary]

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-23
Device Publish Date2016-11-18

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