Home › Icad, Inc. › DynaLOC Breast Interventional Planning Software

DynaLOC Breast Interventional Planning Software

Icad, Inc. · Model 3.5 · UDI-DI 00858012005779

LLZ Prescription

510(k) clearances

19,647

Adverse events (41 deaths)

554

Recalls

633

Facilities

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.

Recalls

Date	Firm	Reason
2026-07-22	Merge Healthcare, Inc.	Software issue may cause measurements to be displayed inaccurately.
2026-07-22	FUJIFILM Healthcare Americas Corporation	Software issue may cause the ruler measurement to be inaccurate.
2026-06-30	Merge Healthcare, Inc.	Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st
2026-06-30	Merge Healthcare, Inc.	Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st
2026-06-19	Boston Scientific Corporation	Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu
2026-05-08	GE Medical Systems SCS	GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches
2026-03-19	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide re
2026-03-05	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
2026-01-30	GE Medical Systems, LLC	There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w
2026-01-30	GE Medical Systems, LLC	There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.