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Sign in to claim this brandImpac Medical Systems, Inc.
US
Last updated May 23, 2026
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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 |
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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.
| 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. |