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DynaLOC Breast Interventional Planning Software

FDA UDI

Class II (US FDA UDI)

by Icad, Inc.

Identity

Trade Name
DynaLOC Breast Interventional Planning Software FDA UDI
Generic Name
Radiological PACS software FDA UDI
Device Name
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. FDA UDI
Model / Reference
3.5 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
D75014-05, D57015-05 FDA UDI
Primary DI / UDI-DI
00858012005779 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiological PACS software

DynaLOC Breast Interventional Planning Software by Icad, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological PACS software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icad, Inc.

Sources (1)

  • FDA UDI ad9d710e-5971-4416-bfe0-2f60b5941a99 35 fields · synced May 30, 2026