MEDICAL IMAGING SALE AND SERVICE INC
Registration 3021059265FEI 3021059265Farmingdale, NJ
Owner/operator: medical imaging sale and service Inc
- Repack or Relabel Medical Device
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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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 42
- Added, last 12 months
- 18
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
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.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
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 42
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| MOS | Siemens Medical SolutionsCoil, Magnetic Resonance, Specialty | Class 2 | 21 CFR 892.1000 | K190138 |
| MOS | Siemens MAGNETOM AvantoCoil, Magnetic Resonance, SpecialtyAdded Jan 8, 2026 | Class 2 | 21 CFR 892.1000 | K181613 |
| MOS | Siemens MAGNETOM AeraCoil, Magnetic Resonance, SpecialtyAdded Jan 8, 2026 | Class 2 | 21 CFR 892.1000 | K231560 |
| MUE | Siemens Medical SystemsFull Field Digital, System, X-Ray, Mammographic | Class 2 | 21 CFR 892.1715 | K122286 |
| MUE | Hologic, Inc. Digital MammogramFull Field Digital, System, X-Ray, MammographicAdded Jan 8, 2026 | Class 2 | 21 CFR 892.1715 | K123873 |
| OXO | GE HealthcareImage-Intensified Fluoroscopic X-Ray System, Mobile | Class 2 | 21 CFR 892.1650 | K133278 |
| OXO | GE HealthcareImage-Intensified Fluoroscopic X-Ray System, Mobile | Class 2 | 21 CFR 892.1650 | K122234 |
| OWB | GE HealthcareInterventional Fluoroscopic X-Ray System | Class 2 | 21 CFR 892.1650 | K122234 |
| OWB | Siemens Medical SolutionsInterventional Fluoroscopic X-Ray System | Class 2 | 21 CFR 892.1650 | K181407 |
| OWB | GE HealthcareInterventional Fluoroscopic X-Ray System | Class 2 | 21 CFR 892.1650 | K133278 |
| MQB | GE HealthcareSolid State X-Ray Imager (Flat Panel/Digital Imager) | Class 2 | 21 CFR 892.1680 | K173612 |
| LNH | GE Medical SystemsSystem, Nuclear Magnetic Resonance Imaging | Class 2 | 21 CFR 892.1000 | K052293 |
and 30 more on your full dossier
What changed
- Jan 8, 2026Listing added: MOS — Siemens MAGNETOM Avanto (K181613)
- Jan 8, 2026Listing added: MOS — Siemens MAGNETOM Aera (K231560)
- Jan 8, 2026Listing added: MUE — Hologic, Inc. Digital Mammogram (K123873)
- Jan 8, 2026Listing added: LNH — Siemens MAGNETOM Aera (K231560)
- Jan 8, 2026Listing added: LNH — Siemens MAGNETOM Avanto (K181613)
- Jan 8, 2026Listing added: LNI — Siemens MAGNETOM Avanto (K181613)
- Jan 8, 2026Listing added: LNI — Siemens MAGNETOM Aera (K231560)
- Jan 8, 2026Listing added: KPS — Siemens Symbia SPECT and SPECT/CT Systems (K241898)
- Mar 20, 2026Listing added: KPS — Symbia (K212604)
- Mar 18, 2026Listing added: JAK — DISCOVERY CT750 HD (K120833)
- Mar 18, 2026Listing added: JAK — OPTIMA CT520 (K123596)
- Jan 8, 2026Listing added: JAK — Siemens Symbia SPECT and SPECT/CT Systems (K241898)
- Jan 8, 2026Listing added: JAK — Toshiba AQUILION PRIME (K110066)
- Jan 8, 2026Listing added: JAK — Siemens SOMATOM Definition AS Open (K142955)
- Mar 13, 2026Listing added: JAK — CT660 Cj2.5 Upgrade (K131576)
- Jan 8, 2026Listing added: JAK — Philips iCT CT System (K162838)
- Mar 20, 2026Listing added: JAK — Symbia (K212604)
- Jan 8, 2026Listing added: JAK — Siemens SOMATOM X.ceed (K233650)