United Imaging Healthcare North America, Inc
Registration 3011950073FEI 3011950073Houston, TX
Owner/operator: United Imaging Healthcare North America, Inc
- Complaint File Establishment per 21 CFR 820.198
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 60
- Added, last 12 months
- 60
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The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
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Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 60
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| QIH | Automated Radiological Image Processing SoftwareRadiologyAdded Mar 19, 2026 | Class 2 | 21 CFR 892.2050 | K252371 |
| QIH | Automated Radiological Image Processing SoftwareRadiologyAdded Mar 19, 2026 | Class 2 | 21 CFR 892.2050 | K250246 |
| QIH | Automated Radiological Image Processing SoftwareRadiologyAdded Mar 19, 2026 | Class 2 | 21 CFR 892.2050 | K243397 |
| MOS | Coil, Magnetic Resonance, SpecialtyRadiologyAdded Mar 19, 2026 | Class 2 | 21 CFR 892.1000 | K243397 |
| MOS | Coil, Magnetic Resonance, SpecialtyRadiologyAdded Mar 19, 2026 | Class 2 | 21 CFR 892.1000 | K243122 |
| MOS | Coil, Magnetic Resonance, SpecialtyRadiologyAdded Mar 19, 2026 | Class 2 | 21 CFR 892.1000 | K252371 |
| MOS | uPMR 790Coil, Magnetic Resonance, SpecialtyAdded Mar 19, 2026 | Class 2 | 21 CFR 892.1000 | K234154 |
| MOS | Coil, Magnetic Resonance, SpecialtyRadiologyAdded Mar 19, 2026 | Class 2 | 21 CFR 892.1000 | K240744 |
| MOS | Coil, Magnetic Resonance, SpecialtyRadiologyAdded Mar 19, 2026 | Class 2 | 21 CFR 892.1000 | K250246 |
| OWB | Interventional Fluoroscopic X-Ray SystemRadiologyAdded Mar 19, 2026 | Class 2 | 21 CFR 892.1650 | K243376 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager)RadiologyAdded Mar 19, 2026 | Class 2 | 21 CFR 892.1680 | K192293 |
| LNH | System, Nuclear Magnetic Resonance ImagingRadiologyAdded Mar 19, 2026 | Class 2 | 21 CFR 892.1000 | K193200 |
and 48 more on your full dossier
What changed
- Mar 19, 2026Listing added: QIH — Automated Radiological Image Processing Software (K252371)
- Mar 19, 2026Listing added: QIH — Automated Radiological Image Processing Software (K250246)
- Mar 19, 2026Listing added: QIH — Automated Radiological Image Processing Software (K243397)
- Mar 19, 2026Listing added: MOS — Coil, Magnetic Resonance, Specialty (K243397)
- Mar 19, 2026Listing added: MOS — Coil, Magnetic Resonance, Specialty (K243122)
- Mar 19, 2026Listing added: MOS — Coil, Magnetic Resonance, Specialty (K252371)
- Mar 19, 2026Listing added: MOS — uPMR 790 (K234154)
- Mar 19, 2026Listing added: MOS — Coil, Magnetic Resonance, Specialty (K240744)
- Mar 19, 2026Listing added: MOS — Coil, Magnetic Resonance, Specialty (K250246)
- Mar 19, 2026Listing added: OWB — Interventional Fluoroscopic X-Ray System (K243376)
- Mar 19, 2026Listing added: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager) (K192293)
- Mar 19, 2026Listing added: LNH — System, Nuclear Magnetic Resonance Imaging (K193200)
- Mar 19, 2026Listing added: LNH — System, Nuclear Magnetic Resonance Imaging (K243122)
- Mar 19, 2026Listing added: LNH — System, Nuclear Magnetic Resonance Imaging (K252371)
- Mar 19, 2026Listing added: LNH — System, Nuclear Magnetic Resonance Imaging (K222755)
- Mar 19, 2026Listing added: LNH — System, Nuclear Magnetic Resonance Imaging (K230152)
- Mar 19, 2026Listing added: LNH — System, Nuclear Magnetic Resonance Imaging (K250246)
- Mar 19, 2026Listing added: LNH — System, Nuclear Magnetic Resonance Imaging (K240744)
- Mar 19, 2026Listing added: LNH — System, Nuclear Magnetic Resonance Imaging (K243397)
- Mar 19, 2026Listing added: LNH — System, Nuclear Magnetic Resonance Imaging (K243547)
- Mar 19, 2026Listing added: KPS — System, Tomography, Computed, Emission (K193241)
- Mar 19, 2026Listing added: KPS — uEXPLORER (K231762)
- Mar 19, 2026Listing added: KPS — System, Tomography, Computed, Emission (K182237)
- Mar 19, 2026Listing added: KPS — System, Tomography, Computed, Emission (K241585)
- Mar 19, 2026Listing added: KPS — System, Tomography, Computed, Emission (K253564)
- Mar 19, 2026Listing added: KPS — System, Tomography, Computed, Emission (K223325)
- Mar 19, 2026Listing added: KPS — System, Tomography, Computed, Emission (K182938)
- Mar 19, 2026Listing added: KPS — System, Tomography, Computed, Emission (K231572)
- Mar 19, 2026Listing added: KPS — System, Tomography, Computed, Emission (K243538)
- Mar 19, 2026Listing added: KPS — System, Tomography, Computed, Emission (K232712)
- Mar 19, 2026Listing added: KPS — System, Tomography, Computed, Emission (K251839)
- Mar 19, 2026Listing added: KPS — System, Tomography, Computed, Emission (K241596)
- Mar 19, 2026Listing added: JAA — System, X-Ray, Fluoroscopic, Image-Intensified (K243376)
- Mar 19, 2026Listing added: IZL — System, X-Ray, Mobile (K242515)
- Mar 19, 2026Listing added: KPR — System, X-Ray, Stationary (K252000)
- Mar 19, 2026Listing added: KPR — System, X-Ray, Stationary (K241068)
- Mar 19, 2026Listing added: KPR — System, X-Ray, Stationary (K173953)
- Mar 19, 2026Listing added: KPR — System, X-Ray, Stationary (K251167)
- Mar 19, 2026Listing added: KPR — System, X-Ray, Stationary (K192293)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K232712)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K241585)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K253173)
- Mar 19, 2026Listing added: JAK — uEXPLORER (K231762)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K200016)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K253564)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K243617)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K231572)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K241596)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K251839)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K231482)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K241079)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K241166)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K182237)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K182938)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K230162)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K223325)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K193241)
- Mar 19, 2026Listing added: JAK — System, X-Ray, Tomography, Computed (K243538)
- Mar 19, 2026Listing added: OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance (K192672)
- Mar 19, 2026Listing added: OUO — uPMR 790 (K234154)