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Impac Medical Systems, Inc.

Last updated May 23, 2026

What Impac Medical Systems, Inc. makes

Impac Medical Systems develops software-based systems for radiation therapy planning, delivery, and management, including oncology information platforms, treatment planning tools, and simulation systems. Their portfolio includes systems for multi-leaf collimator fitting, virtual simulation, and imaging integration, designed to support radiotherapy workflows in clinical settings.

The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. Their products are intended for use in the United States, where they are subject to compliance with FDA requirements for medical software and radiation therapy equipment.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Impac Medical Systems, Inc. manufacture?

Impac Medical Systems, Inc. specializes in software-based medical devices primarily used in radiation therapy. Their portfolio includes oncology information systems (like MOSAIQ), treatment planning tools (such as Monaco), simulation systems (including QWIKSIM Virtual Simulation), and ancillary software for workflow integration (e.g., MLC FIT for multi-leaf collimator fitting and IMAGERT for imaging). These devices are designed to streamline radiotherapy planning, delivery, and management in clinical environments.

Where is Impac Medical Systems, Inc. based, and where are its devices intended for use?

Impac Medical Systems, Inc. is based in the United States. Their devices are specifically developed and marketed for use within the U.S., where they must comply with FDA regulations governing medical software and radiation therapy equipment. The regulatory framework ensures these products meet safety, performance, and effectiveness standards for clinical applications.

How are Impac Medical Systems’ devices classified under FDA regulations?

Impac Medical Systems’ devices are classified as Class II under FDA regulations. This classification applies to products that pose moderate risk and require special controls to ensure their safety and effectiveness. Since these devices are software-based and integral to radiation therapy workflows, they undergo a 510(k) clearance process to demonstrate substantial equivalence to legally marketed predicate devices, ensuring compliance with FDA requirements.

Which regulatory registries or databases list Impac Medical Systems’ devices?

Impac Medical Systems’ devices are listed in the FDA’s 510(k) clearance database. This registry tracks medical devices that have undergone the 510(k) premarket notification process, confirming they meet FDA requirements for safety and performance. The listing provides transparency on cleared devices, including their classification, intended use, and compliance history.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
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Catalogue (33)

Device	Model / Reference	Registries	Class	Status
Pocket Dop 3	K910462	FDA 510(k)	Class II	Active
Doplette 10	K851269	FDA 510(k)	Class II	Active
Mosaiq Oncology Information System	K141572	FDA 510(k)	Class II	Active
Ultrasound Scanner 501	K834284	FDA 510(k)	Class II	Active
Imex Futuraldop Pro	K970156	FDA 510(k)	Class II	Active
Riser Standup Wheelchair	K832696	FDA 510(k)	Class II	Active
Imex Stethodop	K973336	FDA 510(k)	Class II	Active
1mhz Cw Doppler Transducer W/Lily Antepartum #507	K860621	FDA 510(k)	Class II	Active
Vascular Recorder #301	K832369	FDA 510(k)	Class II	Active
Mlc Fit	K962335	FDA 510(k)	Class II	Active
Sequencer	K913612	FDA 510(k)	Class II	Active
Mascot Stethoscope Probe	K874726	FDA 510(k)	Class II	Active
Viewstation	K011694	FDA 510(k)	Class II	Active
Non Stress Test Monitor 507	K840285	FDA 510(k)	Class II	Active
Imexdop Ct+	K942441	FDA 510(k)	Class II	Active
Mosaiq Oncology Information System	K120067	FDA 510(k)	Class II	Active
Monaco	K151233	FDA 510(k)	Class II	Active
Mascot Cw Doppler System	K871212	FDA 510(k)	Class II	Active
Imex Medical Systems, Inc. Imexlab 9000	K973556	FDA 510(k)	Class II	Active
Imex 8000 Personal Cascular Lab	K942243	FDA 510(k)	Class II	Active
Pulse Cuff Recorder Model Pcr100	K863702	FDA 510(k)	Class II	Active
Imexlab 3000 Vascular Diagnostic Recorder	K882138	FDA 510(k)	Class II	Active
Imex Dop-Tone Ii	K901593	FDA 510(k)	Class II	Active
Imex Medical Systems, Inc. Imexlab 9100	K973562	FDA 510(k)	Class II	Active
Modification To: Viewstation	K043412	FDA 510(k)	Class II	Active
Imagert	K942346	FDA 510(k)	Class II	Active
Sequencer	K981313	FDA 510(k)	Class II	Active
Mosaiq Oncology Information System	K123230	FDA 510(k)	Class II	Active
Qwiksim Virtual Simulation System; Version 2.00	K013531	FDA 510(k)	Class II	Active
Imwxdop Ir	K944196	FDA 510(k)	Class II	Active
Monaco	K132971	FDA 510(k)	Class II	Active
Flat Vascular Probe	K896613	FDA 510(k)	Class II	Active
Mlc Fit	K991133	FDA 510(k)	Class II	Active

Related Companies

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FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Impac Medical Systems, Inc. has eight recall records initiated between February 14, 2008, and June 8, 2012, all marked as terminated. The reasons cited involve software issues, including potential changes to treatment fields, incorrect motor unit recordings, mismatched patient data, and errors in gantry angle settings during database conversions, which may affect treatment parameters. Additional concerns include defects in computer interfaces for verifying patient treatments and potential dosing inaccuracies due to mechanical or software malfunctions.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jun 8, 2012	Z-1944-2012	—	terminated	Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zero.
Sep 9, 2011	Z-0052-2012	—	terminated	Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq.
Mar 10, 2011	Z-2662-2011	—	terminated	There's a problem in the database conversion program that is used when upgrading from the Multi-ACCS to MOSAIQ or from one version of MOSAIQ to another. If the gantry start angle is incorrect prior to pressing beam-on, the patient will be mistreated.
Sep 2, 2010	Z-0076-2011	—	terminated	Software issue-- matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different patient.
Mar 10, 2010	Z-1029-2011	—	terminated	Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field.
Feb 19, 2010	Z-0159-2011	—	terminated	Mistreatment-- The database conversion utility used during the upgrade errantly changes the start gantry angle to zero. Any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value.
Jul 17, 2009	Z-1027-2011	—	terminated	Potential for improper treatment. A software error may result in potential major underdosing to targeted areas from jaw blockage of the MLC aperture (jaw intrusion), and dosing to non-targeted areas from interstitial leaf leakage (jaw extrusion).
Feb 14, 2008	Z-1515-2008	—	terminated	Software issue may result in change to intended treatment field, potentially resulting in mistreatment.