Data / Medical devices / Mexico / Ge Medical Systems Monterrey Mexico, S.A. De C.V.
Ge Medical Systems Monterrey Mexico, S.A. De C.V.: FDA-registered device maker in APODACA Nuevo Leon, Mexico, 22 510(k) clearances
Ge Medical Systems Monterrey Mexico, S.A. De C.V. is registered with the FDA (registration 9616047) in APODACA Nuevo Leon, Mexico. It lists 18 device types. The FDA files 22 510(k) clearances under its listings, the newest dated April 20, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9616047
- FEI number
- 3003377038
- Address
- CALLE ESPANA No. 300 PARQUE INDUSTRIAL HUINALA, APODACA Nuevo Leon, Mexico, C.P.66645
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer
- First device listed
- March 16, 1978
- Registered through
- 2027
- Brand names listed
- 1.5T Detachable Table, 1.5T GEM Anterior Array, 1.5T GEM HNU, 1.5T GEM PA, 1.5T GEM PVA, 1.5T Split Head Coil, 1.5T eXpress Table, 3T Detachable Table and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 20, 2026 | K252718 | Lunar Astra | KGI | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| April 14, 2026 | K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | QIH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 28, 2025 | K250788 | Definium Tempo Select | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| October 1, 2024 | K242678 | Definium Pace Select ET | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| May 25, 2023 | K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | QBS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 29, 2021 | K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm | QIH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 28, 2021 | K210982 | AMX Navigate | IZL | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 13, 2020 | K202966 | SIGNA Architect | LNH | Substantially Equivalent | Ge Healthcare (Ge Medical Systems, LLC) | accessdata.fda.gov |
| September 19, 2019 | K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | KGI | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| August 12, 2019 | K183182 | Critical Care Suite | QFM | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| July 24, 2019 | K191699 | Discovery XR656 HD with VolumeRad | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| March 17, 2017 | K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| December 2, 2016 | K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | KGI | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| June 9, 2016 | K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 26, 2014 | K142085 | DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| May 15, 2014 | K133664 | ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS | KGI | Substantially Equivalent | Ge Medical Systems Ultrasound & Primary Care Diagn | accessdata.fda.gov |
| January 13, 2012 | K113490 | OPTIMA MR450W | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 30, 2011 | K103327 | DISCOVERY MR750W 3.0T | LNH | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| March 7, 2011 | K103335 | GEM OPTION FOR 1.5 MRI SYSTEMS | MOS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| July 17, 2009 | K091536 | OPTIMA MR450W | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 20, 2005 | K052581 | LUNAR IDXA | KGI | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Dia | accessdata.fda.gov |
| August 18, 1998 | K982267 | DPX-RX BONE DENSITOMETER | KGI | Substantially Equivalent | Lunar Corp. | accessdata.fda.gov |
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Updated April 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.