HM PRODUCT SOLUTIONS, LTD.

FDA Device Registration & Listing · Hartland, WI, US · Registration 3008355361

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008355361
FEI Number
3008355361
Entity Name
HM PRODUCT SOLUTIONS, LTD.
City/State/Country
Hartland, WI, US
Establishment Address
581 S Industrial Dr, Hartland, WI 53029, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
HM Product Solutions, Ltd. (Owner Number: 10044642)
Owner / Operator Contact Address
581 S. Industrial Drive, Hartland, WI 53029, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

VIRTUTRAX INSTRUMENT NAVIGATOR HD23 SW Upgrade CardIQ Xpress Process Volume Viewer Reporting Tool Disc 710 and 610 64sl Applications AW 4.4 (AW Volume Share 2) PET VCAR AW Server Revolution EVO P3.6-A QR Application GSI Viewer 2 Motion Vue VesselIQ Xpress Thoracic VCAR Seno Advantage Ready View Columbia 1 Applications SMARTSCORE Motion View Universal Viewer Zero Footprint client CadStream

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-03-06
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2020-12-14
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2020-12-14
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2020-12-14
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2013-11-18
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-07-08
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2013-07-08
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-07-08
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2020-12-14
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-07-08
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2013-11-18
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2013-11-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-07-08
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-12-14
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2013-07-08
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2014-12-12
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2013-07-08
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-07-08
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-07-08
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-07-08
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-12-14
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2020-12-14
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2014-12-12
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2013-07-08
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2014-12-12
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-07-08

Official Correspondent

Robert Maynor

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HM Product Solutions, Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K882805 Coopervision-Cilco CILCO VILLASENOR PACHYMETER 1988-08-12
K791040 Shimadzu Corp. SECTOR SCANNER, SDU-100, COMPUTERIZED 1979-10-04
K162372 Qt Ultrasound, LLC QT Ultrasound Breast Scanner-1 2017-06-06
K930964 Acuson Corp. ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) 1994-10-26
K052355 U-Systems, Inc. AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS 2005-09-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011 Verathon, Inc. 2
AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011 Verathon, Inc. 2
BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014 SonoSite, Inc. 2
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0029-2007 Hitachi Medical Systems America Inc 2
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008355361. Last updated year: 2026. Please use registration number 3008355361 when referencing this establishment in official correspondence.
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