BAY SHORE MEDICAL EQUIPMENT, LLC

FDA Device Registration & Listing · Manorville, NY, US · Registration 3005810333

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
3005810333
FEI Number
3005810333
Entity Name
BAY SHORE MEDICAL EQUIPMENT, LLC
City/State/Country
Manorville, NY, US
Establishment Address
61 Deer Lane, Manorville, NY 11949, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Bay Shore Medical Equipment, LLC (Owner Number: 10037139)
Owner / Operator Contact Address
61 Deer Lane, Manorville, NY 11949, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Philips Bucky Diagnost CS Philips Bucky Diagnost VE Philips Bucky Diagnost TH Philips Bucky Diagnost VT Logiq P5 Ultrasound GE OEC 9800 Plus C-arm GE OEC 9800 C-arm Siemens Somatom Sensation 16 CT Scanner Siemens Somatom Sensation 64 CT Scanner Siemens Somatom Sensation 40 CT Scanner Siemens Somatom Sensation 64 Cardiac CT Scanner Siemens Mobilette XP Hybrid Siemens Mobilette XP Siemens Mobilette XP Eco Siemens Symphony Fuji XG1 CR Reader Fuji Clearview CSM CR Reader, Fuji Profect CR Reader Philips Allura Xper FD10 Cath Lab Lorad MIV Mammography Unit Philips 1.5T Intera MRI Scanner GE OEC Flexview 8800 C-arm GE Logiq 9 Transduccers (3.5c, 3.5cs, M7C, 8C, E8C, 7L, M8L, 10L, i12L, M12L, 3S, 7S, 10S, 2D, 6D) GE Logiq 9 Ultrasound Siemens Avanto 1.5T 18 Channel MRI Machine FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L GE Brightspeed Elite GE Brightspeed Elite Select BrightSpeed Excel Select BrightSpeed Edge Select Brightspeed 16 Philips Achieva 3T MRI Scanner Kodak CR Reader Kodak 5800 LAser Imager GE AMX III X-Ray, GE AMX IV portable X-Ray Siemens Siremobil Compact L C-arm Philips BV29 C-arm Philips Practix Convenio Siemens Ecat Accel PET Scanner GE Highspeed CT/e Dual CT Scanner GE Prospeed F2 CT Scanner GE Lightspeed 16 CT scanner Siemens Mammomat Inspiration Mammography Machine Siemens Mammomat Inspiration Philips Intera 1.5T MRI Scanner OPTIMA MR450W 1.5T DISCOVERY MR450 1.5T Fuji Clearview CRM CR reader Fuji Clearview CSM CR reader Fuji Profect CS CR reader (japanese name) SIEMENS ECAT ACCEL PET SCANNER Siemens 1.5 Espree MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS Philips Allura Bi-plane Cath Lab OEC 9900 Elite GE Discovery 600 PET CT Discovery 600 PET CT GE LightSpeed QXI CT Scanner GE LightSpeed Plus CT Scanner GE HighSpeed QXI CT Scanner GE LightSpeed QX/I CT Scanner GE Voluson I Ultrasound, GE Voluson E Ultrasound GE Vivid I Ultrasound GE 1.5 SIGNA EXCITE MRI Toshiba Aquillion CT Scanner GE AMX4 Plus Portable X-ray GE AMX4 Portable X-ray

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2014-06-27
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2014-06-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2015-11-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2015-11-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2015-11-20
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2017-03-22
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2017-03-22
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2017-03-22
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2014-05-16
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2014-10-24
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2014-09-17
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2014-08-29
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2015-03-02
IZH System, X-Ray, Mammographic Radiology Class 2 892.1710 2014-01-07
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2016-02-01
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2017-03-22
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2017-03-22
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-11-18
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-11-18
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-11-18
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-03-09
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2018-03-09
LMC Camera, Multi Format, Radiological Radiology Class 2 892.2040 2014-08-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2013-08-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2016-02-16
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2014-09-23
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2014-11-19
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2018-04-06
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2011-06-21
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2014-07-24
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2015-08-06
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2015-11-12
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2015-10-13
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2017-09-28
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2014-02-12
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-04-24
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2015-09-23
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2015-07-15
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2016-12-22
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2016-12-22
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2012-03-01
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2014-08-20
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2018-09-10
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2018-09-10
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2018-09-10
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2022-04-11
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2015-05-01
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2014-08-29
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-08-29
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2014-08-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2018-08-02
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-08-02
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-08-02
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-10-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2013-03-21
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2014-10-24

Official Correspondent

John Kollegger

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bay Shore Medical Equipment, LLC
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
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16
K190691 Pixxgen Corporation Pixx2430 Digital Diagnostic X-Ray Receptor Panel 2019-04-04
K150150 Rayence Co., Ltd. 1717SGN / 1717SCN Digital Flat Panel X-ray Detector 2015-03-27
K140771 Philips Medical Systems Dmc GmbH PHILIPS ELEVA WORKSPOT 2014-04-25
K201670 Siemens Medical Solutions USA, Inc. YSIO X.pree 2020-10-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2009 Toshiba American Medical Systems Inc 2
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-0002-2009 GE Medical Systems, LLC 2
Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
Z-0002-2015 Siemens Medical Solutions USA, Inc 2
Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Z-0003-2009 GE Medical Systems, LLC 2
Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005810333. Last updated year: 2026. Please use registration number 3005810333 when referencing this establishment in official correspondence.
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