Data / Medical devices / United States / Bay Shore Medical Equipment, LLC
Bay Shore Medical Equipment, LLC: FDA-registered device maker in Manorville, NY, United States, 49 510(k) clearances and 1 PMA approval
Bay Shore Medical Equipment, LLC is registered with the FDA (registration 3005810333) in Manorville, NY, United States. It lists 18 device types. The FDA files 49 510(k) clearances and 1 PMA approval under its listings, the newest dated November 15, 2013. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005810333
- Address
- 61 Deer Lane, Manorville, NY, United States, 11949
- Owner or operator
- Bay Shore Medical Equipment, LLC (10037139)
- Roles
- Repackager or relabeler
- First device listed
- June 21, 2011
- Registered through
- 2026
- Brand names listed
- BrightSpeed Edge Select, BrightSpeed Excel Select, Brightspeed 16, DISCOVERY MR450 1.5T, Discovery 600 PET CT, FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L, Fuji Clearview CRM CR reader Fuji Clearview CSM CR reader Fuji Profect CS CR reader (japanese name), Fuji Clearview CSM CR Reader, Fuji Profect CR Reader 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 |
|---|---|---|---|---|---|---|
| November 15, 2013 | K132376 | DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T | LNH | Substantially Equivalent | Ge Healthcare (Ge Medical Systems, LLC) | accessdata.fda.gov |
| September 24, 2013 | K131937 | VOLUSON I/E | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| May 21, 2013 | K130842 | ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES | IZI | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| February 22, 2013 | K122286 | MAMMOMAL INSPIRATION | MUE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 16, 2012 | K122234 | OEC 9900 ELITE | OWB | Substantially Equivalent | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | accessdata.fda.gov |
| April 6, 2012 | K120613 | OEC 9900 ELITE | OXO | Substantially Equivalent | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | accessdata.fda.gov |
| December 8, 2011 | K111646 | ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR | MUE | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. | accessdata.fda.gov |
| September 1, 2011 | K112213 | VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 21, 2009 | K092140 | GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND | IYO | Substantially Equivalent | Ge Medical Systems Israel, Ultrasound, Ltd. | accessdata.fda.gov |
| October 8, 2008 | K082816 | GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 8, 2008 | K082761 | GE LIGHTSPEED 7.2 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 12, 2008 | K081496 | OPTIMA PET/CT 560 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 4, 2007 | K063559 | ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 | LNH | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| May 3, 2006 | K060993 | GE LOGIQ P5 AND A5 | IYN | Substantially Equivalent | General Electric Co. | accessdata.fda.gov |
| February 23, 2005 | K050380 | XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A | IYN | Substantially Equivalent | Toshiba America Medical Systems, In.C | accessdata.fda.gov |
| October 4, 2004 | K042368 | PRACTIX CONVENIO | IZL | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
| August 25, 2004 | K042023 | FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER | MQB | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. | accessdata.fda.gov |
| July 30, 2004 | K041949 | ALLURA XPER FD10 | IZI | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
| July 21, 2004 | K041112 | MAGNETOM ESPREE SYSTEM | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 17, 2004 | K041476 | GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 2, 2004 | K040665 | SOMATOM SENSATION 64 AND SENSATION CARDIAC | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 9, 2004 | K033377 | FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L | LMC | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. | accessdata.fda.gov |
| November 14, 2003 | K033238 | MOBILETTE XP AND MOBILETT XPHYBRID | IZL | Substantially Equivalent | Siemens Medical Systems, Inc. | accessdata.fda.gov |
| November 10, 2003 | K033418 | TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS | JAK | Substantially Equivalent | Toshiba America Medical Systems, In.C | accessdata.fda.gov |
| October 29, 2003 | K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM | JAK | Substantially Equivalent | Philips Medical Systems, Inc. | accessdata.fda.gov |
| October 16, 2003 | K032428 | MAGNETOM AVANTO MR SYSTEM | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 17, 2003 | K030934 | GE LOGIQ 9 MODEL 2375600 | IYN | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| July 2, 2002 | K021829 | MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM | MQB | Substantially Equivalent | Eastman Kodak Company | accessdata.fda.gov |
| June 17, 2002 | K021016 | AMX-4 PLUS MOBILE X-RAY SYSTEM | IZL | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| May 22, 2002 | K021491 | HISPEED DUAL | JAK | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| April 17, 2002 | K021049 | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM | OWB | Substantially Equivalent | Ge Oec Medical Systems | accessdata.fda.gov |
| December 11, 2001 | K013344 | INTERA I/T | LNH | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
| November 8, 2001 | K013561 | LIGHTSPEED 4.0 CT SCANNER SYSTEM | JAK | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| March 12, 2001 | K010435 | PHILIPS BV PULSERA/ENDURA | OWB | Substantially Equivalent | Philips Medical Systems, Inc. | accessdata.fda.gov |
| March 12, 2001 | K003837 | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM | OXO | Substantially Equivalent | Ge Oec Medical Systems | accessdata.fda.gov |
| November 16, 2000 | K002584 | ECAT ACCEL PET SCANNER | KPS | Substantially Equivalent | Cti Pet Systems, Inc. | accessdata.fda.gov |
| September 6, 2000 | K001796 | GYROSCAN INTERA (R7.5) | LNH | Substantially Equivalent | Philips Medical Systems North America, Inc. | accessdata.fda.gov |
| November 10, 1999 | K992731 | E.CAM COMPUTER | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 8, 1999 | K992135 | SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM | LNH | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| November 24, 1998 | K982795 | PHILIPS BUCKY VISION | MQB | Substantially Equivalent | Philips Medical Systems, Inc. | accessdata.fda.gov |
| October 21, 1998 | K982787 | ASTEION CT SCANNER, TSX-021A | JAK | Substantially Equivalent | Toshiba America Medical Systems, In.C | accessdata.fda.gov |
| April 13, 1998 | K980176 | HISPEED QX/I CT SCANNER SYSTEM | JAK | Substantially Equivalent | General Electric Co. | accessdata.fda.gov |
| August 5, 1997 | K971684 | MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 10, 1996 | K962738 | MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS | KPS | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| September 3, 1996 | K963093 | SIREMOBIL COMPACT | OXO | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 3, 1992 | K913732 | MAMMOGRAPHIC X-RAY SYSTEM | IZH | Substantially Equivalent | Lorad Medical Systems, Inc. | accessdata.fda.gov |
| February 20, 1991 | K910115 | PHILIPS BV-29 IMAGING SYSTEM | OXO | Substantially Equivalent | Philips Medical Systems, Inc. | accessdata.fda.gov |
| November 6, 1990 | K902983 | SIEMEN'S SIREMOBILE II C-ARM | JAA | Substantially Equivalent | Electromek Diagnostic Systems, Inc. | accessdata.fda.gov |
| October 23, 1980 | K802047 | AMX-III | IZL | Substantially Equivalent | General Electric Co. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 11, 2011 | P080003 | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | OTE | 10 | November 24, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
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- All makers of Full Field Digital, System, X-Ray, Mammographic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated November 24, 2025. 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.