Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- EAGCephalometer2Product Code
- EAHCone, Radiographic, Lead-Lined1Product Code
- EAPUnit, X-Ray, Intraoral2Product Code
- EHBCollimator, X-Ray1Product Code
- EHDUnit, X-Ray, Extraoral With Timer2Product Code
- MUHSystem, X-Ray, Extraoral Source, Digital2Product Code
- EAMScreen, Intensifying, Radiographic1Product Code
- EGTController, Temperature, Radiographic2Product Code
- EGWDryer, Film, Radiographic2Product Code
- EGYProcessor, Radiographic-Film, Automatic, Dental2Product Code
- HBKChair, Pneumoencephalographic2Product Code
- ITXTransducer, Ultrasonic, Diagnostic2Product Code
- K241662Ultrasound Transducer Cover2Cleared 510(K)
- K233965UltraDrape UGPIV Barrier and Securement (34-15)2Cleared 510(K)
- K241615Transducer Probe Cover2Cleared 510(K)
- K233109TP Pivot Pro™ Needle Guide2Cleared 510(K)
- K231666Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)2Cleared 510(K)
- K231783VitroPRO2Cleared 510(K)
- K223689Disposable Needle Guides and Grids2Cleared 510(K)
- K222460Intraoperative Ultrasound Probe Cover2Cleared 510(K)
- K221278Transducer Probe Cover2Cleared 510(K)
- K222052VitroPRO2Cleared 510(K)
- K213087Natural Rubber Latex Ultrasound Transducer Probe Covers2Cleared 510(K)
- K211270CIV-Clear cover2Cleared 510(K)
- K211969EMM Ultrasonic Transducer Cover2Cleared 510(K)
- K201425Disposable Intraoperative Probe (DIOP8)2Cleared 510(K)
- K202035Vscan Air2Cleared 510(K)
- K191491EZ-Cover2Cleared 510(K)
- K200733Opticross 35 15 MHz Peripheral Imaging Catheter2Cleared 510(K)
- K190802Envision ultrasound pad and cover2Cleared 510(K)
- K171272Cook-Swartz Doppler Flow Probe2Cleared 510(K)
- K180970Disposable guides KDNG002Cleared 510(K)
- K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range2Cleared 510(K)
- K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor2Cleared 510(K)
- K170741GTK Disposable Needle Guides2Cleared 510(K)
- K171348Pinpoint GT Needle Guide Kits2Cleared 510(K)
- K170338A-View2Cleared 510(K)
- K163502iSR'obot Biopsy Kit2Cleared 510(K)
- K152126UST-5550-R; UST-5536-R; L43K2Cleared 510(K)
- K160806Verza Guidance System2Cleared 510(K)
- K160414Precision Point Biopsy Needle Guide2Cleared 510(K)
- K153212Sheathes Ultrasound Probe Covers2Cleared 510(K)
- K152403Permanent Sled Bag2Cleared 510(K)
- K142618Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System2Cleared 510(K)
- K141334REUSABLE GUIDE2Cleared 510(K)
- K140854INTRA-OPERATIVE ULTRASOUND TRANSDUCER2Cleared 510(K)
- K1410936VT-D ULTRASOUND TRANSDUCER2Cleared 510(K)
- K131161EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,2Cleared 510(K)
- K131528NON-PYROGENIC ULTRASOUND TRANSDUCER COVER2Cleared 510(K)
- K123424MDU5 PLUS STERILE BAG2Cleared 510(K)
- K122921C1-6-D ULTRASOUND TRANSDUCER2Cleared 510(K)
- K122515C2-9-D ULTRASOUND TRANSDUCER2Cleared 510(K)
- K121062VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K121807V5MS TRANSDUCER2Cleared 510(K)
- K113832SONICEYE ULTRASOUND TRANSDUCER2Cleared 510(K)
- K111426EUCLID (TM) TIER 1-GW ACCESS SYSTEM2Cleared 510(K)
- K120156PUREIMAGE ULTRASOUND TRANSMISSION GEL2Cleared 510(K)
- K110752HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER2Cleared 510(K)
- K101952KONIX ULTRASOUND GEL2Cleared 510(K)
- K111021CUBESCAN / BIOCON-7002Cleared 510(K)
- K110999DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM2Cleared 510(K)
- K110920UF-760AG2Cleared 510(K)
- K110202FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB2Cleared 510(K)
- K103629PET-512MC TRANSESOPHAGEAL TRANSDUCER2Cleared 510(K)
- K110020TERASON T3200 ULTRASOUND SYSTEM2Cleared 510(K)
- K103645APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K103722THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K102865DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K102041AIXPLORER2Cleared 510(K)
- K101816STN PROBE2Cleared 510(K)
- K101757SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM2Cleared 510(K)
- K101829THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K101008DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY2Cleared 510(K)
- K101041DC-7 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K100204SONALIS2Cleared 510(K)
- K100067MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM2Cleared 510(K)
- K093713ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM2Cleared 510(K)
- K093714SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K093462SONIX ULTRASOUND SCANNER2Cleared 510(K)
- K092858SAFERSONIC SONOGRAPHY COVER2Cleared 510(K)
- K092691DC-7 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K092756GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K091828SHEATHESISO ULTRASOUND TRANSDUCER COVER2Cleared 510(K)
- K092637PACSCAN PLUS, MODELS 300P AND 300AP2Cleared 510(K)
- K091877CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL2Cleared 510(K)
- K091804CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS2Cleared 510(K)
- K091941DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K091680DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM2Cleared 510(K)
- K091295APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.02Cleared 510(K)
- K090912DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-69002Cleared 510(K)
- K090465DIGDOP ULTRASOUND SYSTEM2Cleared 510(K)
- K083824HUMANSCAN M5S-D ULTRASOUND TRANSDUCER2Cleared 510(K)
- K083667NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 13372Cleared 510(K)
- K083877FLYING DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K082224DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC2Cleared 510(K)
- K082893PRAGER SHELL2Cleared 510(K)
- K081919UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K081802CX50 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K080970USHIFU STEPPER2Cleared 510(K)
- K080555SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)2Cleared 510(K)
- K073623ATLANTIS 018 PERIPHERAL IMAGING CATHETER2Cleared 510(K)
- K080272ATLANTIS PVIMAGING CATHETER, MODEL H7493645602Cleared 510(K)
- K080119CLEARSCAN2Cleared 510(K)
- K071291ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-11002Cleared 510(K)
- K071287ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO2Cleared 510(K)
- K071289ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO2Cleared 510(K)
- K072786ACUSON S2000 ULTRASOUND SYSTEM2Cleared 510(K)
- K072918MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.002Cleared 510(K)
- K072826APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K070195BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B2Cleared 510(K)
- K072541SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM2Cleared 510(K)
- K072164DC-6 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K072285ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM2Cleared 510(K)
- K072266ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K070515A-VIEW BASIC AND PLUS2Cleared 510(K)
- K070903MYLAB402Cleared 510(K)
- K061153GYNESONICS EC6 TRANSDUCER2Cleared 510(K)
- K061560SONOMARK2Cleared 510(K)
- K060947SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C10202Cleared 510(K)
- K060879MODEL EC9-4 TRANSDUCER2Cleared 510(K)
- K053463AIM ACCURACY IN MARKING SYSTEM2Cleared 510(K)
- K052517SITE-RITE 5 ULTRASOUND SYSTEM2Cleared 510(K)
- K052021V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER2Cleared 510(K)
- K050320FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT2Cleared 510(K)
- K050724SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM2Cleared 510(K)
- K043425SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)2Cleared 510(K)
- K043278TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES2Cleared 510(K)
- K032315IOP8 INTRA OPERATIVE PROBE2Cleared 510(K)
- K041818SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C10202Cleared 510(K)
- K042445SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT2Cleared 510(K)
- K040213MHLX7EC TRANSDUCER2Cleared 510(K)
- K041638TARGETSCAN BIOPSY KIT2Cleared 510(K)
- K041637TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM2Cleared 510(K)
- K041396FG-36UX FIBER ULTRASOUND GASTROSCOPE2Cleared 510(K)
- K041395EG-3630UR2Cleared 510(K)
- K041397EG-3830UT2Cleared 510(K)
- K040840TERATECH MODEL 10V5 SMART PROBE2Cleared 510(K)
- K022156LATEX ULTRASONIC PROBE COVER2Cleared 510(K)
- K031920CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-0012Cleared 510(K)
- K030518AMERITEK SURE-POINT TRACKER SYSTEM2Cleared 510(K)
- K031358TRANSVAGINAL DOPPLER PROBE2Cleared 510(K)
- K030064ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY2Cleared 510(K)
- K022860ATLANTIS PV IMAGING CATHETER, MODEL 364562Cleared 510(K)
- K023024TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-022Cleared 510(K)
- K022649COOK-SWARTZ DOPPLER FLOW PROBE2Cleared 510(K)
- K013363CROSSPOINT TRANSACCESS CATHETER2Cleared 510(K)
- K013723MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER2Cleared 510(K)
- K014182TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS2Cleared 510(K)
- K013721SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER2Cleared 510(K)
- K002958SHAPEABLE DOPPLER FLOW PROBE2Cleared 510(K)
- K013849TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS2Cleared 510(K)
- K013170SCANTAC MEMBRANE OR SCANTAC STRIP2Cleared 510(K)
- K011265ULTRASOUND TRANSDUCER COVER2Cleared 510(K)
- K012522WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL2Cleared 510(K)
- K011581AMERITEK BRACHYTHERAPY TEMPLATE2Cleared 510(K)
- K011284THIN FILM DRESSING FOR ULTRASOUND EXAM2Cleared 510(K)
- K011314OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM2Cleared 510(K)
- K002193TETRAD TC-C3-ACP2Cleared 510(K)
- K010883TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE2Cleared 510(K)
- K002856AT3C70 TRANSDUCER2Cleared 510(K)
- K002784ALOKA UST-5280-52Cleared 510(K)
- K994103OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT2Cleared 510(K)
- K994106OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE2Cleared 510(K)
- K994069OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE2Cleared 510(K)
- K001203OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT2Cleared 510(K)
- K992178BALLOON FOR ULTRASONIC ENDOSCOPES2Cleared 510(K)
- K001016GE LOGIQ 7002Cleared 510(K)
- K994373HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4)2Cleared 510(K)
- K992305MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF20042Cleared 510(K)
- K982208IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER2Cleared 510(K)
- K992152GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF2Cleared 510(K)
- K984639THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER2Cleared 510(K)
- K992155VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-72Cleared 510(K)
- K984562VIVOSONIC2Cleared 510(K)
- K991236GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER,2Cleared 510(K)
- K983691SCANFLEX SOLID COUPLANT MEMBRANE2Cleared 510(K)
- K990175SHEATHES (NON-LATEX), STERILE2Cleared 510(K)
- K983985HYBRISONIC SHEATH2Cleared 510(K)
- K990400LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K982568BLADDERMANAGER PCI 5000 MODEL 10022Cleared 510(K)
- K982329VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)2Cleared 510(K)
- K982323OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE2Cleared 510(K)
- K982610OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT)2Cleared 510(K)
- K982733OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE2Cleared 510(K)
- K982725OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE2Cleared 510(K)
- K981069ULTRA-COVER PU-TRANSDUCER COVER2Cleared 510(K)
- K981028ULTRA IMAGE AND ULTRA SCAN2Cleared 510(K)
- K981434EUP-OL334 LAPARASCOPICPROBE2Cleared 510(K)
- K964001SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM2Cleared 510(K)
- K980091LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-602Cleared 510(K)
- K974544ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER2Cleared 510(K)
- K972771PHASED ARRAY TRANSDUCER - - PVF -375DT2Cleared 510(K)
- K974301CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER2Cleared 510(K)
- K97371322 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR2Cleared 510(K)
- K973958GENERAL PURPOSE ATL NEEDLE GUIDE KIT2Cleared 510(K)
- K971116SONOS 5500 IMAGING SYSTEM2Cleared 510(K)
- K955893EVERYTIME TRANSFUCER COVER2Cleared 510(K)
- K973622TRANSDUCER POSITIONER2Cleared 510(K)
- K973079L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM2Cleared 510(K)
- K973362NEEDLE GUIDE/GRID2Cleared 510(K)
- K971397VIEWCATH 3-D CATHETER PULLBACK2Cleared 510(K)
- K972152DEVMED STEPPING AND STABILIZING SYSTEM2Cleared 510(K)
- K955668INTRACAVITY NEEDLE GUIDE KIT2Cleared 510(K)
- K972672BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY2Cleared 510(K)
- K972348HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM2Cleared 510(K)
- K971942SLED, FINGER, HANDLE2Cleared 510(K)
- K971722TRANS VAGINAL NEEDLE GUIDE2Cleared 510(K)
- K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER2Cleared 510(K)
- K970513GENERAL PURPOSE TRANDUCER COVER2Cleared 510(K)
- K970514DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE2Cleared 510(K)
- K970515GENERAL PURPOSE LATEX TRANSDUCER COVERS2Cleared 510(K)
- K970049BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/2Cleared 510(K)
- K971115GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE2Cleared 510(K)
- K964549ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER2Cleared 510(K)
- K963989P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE2Cleared 510(K)
- K970034SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K964865PVK-720ST ENDOCAVITARY TRANSDUCER2Cleared 510(K)
- K970047PHASED ARRAY TRANSDUCER - - PSK-20CT2Cleared 510(K)
- K964658OASIS2Cleared 510(K)
- K963831SHEATHES (NON-LATEX)2Cleared 510(K)
- K961974FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE2Cleared 510(K)
- K963302TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM2Cleared 510(K)
- K961002DIASONICS ITNRAOPERATIVE PROBES2Cleared 510(K)
- K962840ECOLOTION TRANSMISSION AND MASSAGE LOTION2Cleared 510(K)
- K962093ULTRAMIX2Cleared 510(K)
- K963169RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL2Cleared 510(K)
- K951567CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE2Cleared 510(K)
- K962293ENDOSONICS AUTOMATIC PULL BACK DEVICE2Cleared 510(K)
- K961692SONOSCAN2Cleared 510(K)
- K961757ECOGEL 100 ULTRASOUND GEL2Cleared 510(K)
- K953716INTRACAVITY TRANSDUCERS2Cleared 510(K)
- K953819DIAGNOSTIC ULTRASOUND TRANDUCER2Cleared 510(K)
- K953759DIAGNOSTIC ULTRASOUND TRANSDUCER2Cleared 510(K)
- K955246ECOGEL 200 ULTRASOUND GEL2Cleared 510(K)
- K955458ULTRASOUND PROBE BIOPSY ACCESSORIES2Cleared 510(K)
- K952892OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)2Cleared 510(K)
- K953579TEE PROBE2Cleared 510(K)
- K951723GE B510 TRANSDUCER2Cleared 510(K)
- K953430ULTRASOUND PROBE BIOPSY ACCESSORIES2Cleared 510(K)
- K941935LP-12 LAPAROSCOPIC PROBE2Cleared 510(K)
- K946300DOPPLEX SURGICAL PROBES2Cleared 510(K)
- K951145VMI 1000 SURGICAL PACEOMETER2Cleared 510(K)
- K944017OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM2Cleared 510(K)
- K9442877050 ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K945796SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM2Cleared 510(K)
- K945320TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL2Cleared 510(K)
- K935994PW DOPPLER VASCULAR PROBES2Cleared 510(K)
- K945318TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA2Cleared 510(K)
- K945319TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT2Cleared 510(K)
- K944610OLYMPUS ULTRASONIC PROBES2Cleared 510(K)
- K942296V5M2Cleared 510(K)
- K935595ACUSON MODEL 30012Cleared 510(K)
- K921695ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS2Cleared 510(K)
- K930052SIEMENS QUANTUM 7E11 TRANSRECTAL TRANSDUCER2Cleared 510(K)
- K943637SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K940108DIAGNOSTIC ULTRASOUND IMAGING CATHETER2Cleared 510(K)
- K940671INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER2Cleared 510(K)
- K940804SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION2Cleared 510(K)
- K933663MODIFICATION OF ACUSON V510B TRANSDUCER2Cleared 510(K)
- K925869SHEATHES, STERILE SHEATHES2Cleared 510(K)
- K932777SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER2Cleared 510(K)
- K925434SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A2Cleared 510(K)
- K932536CARDIOMETRICS FLOWIRE & FLOMAP2Cleared 510(K)
- K925081SURFAS2Cleared 510(K)
- K926108VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-8002Cleared 510(K)
- K920882ACUSON V714 TRANSDUCER2Cleared 510(K)
- K925486UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS.2Cleared 510(K)
- K924980CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH2Cleared 510(K)
- K923348OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED2Cleared 510(K)
- K921341ACUSON V714OR TRANSDUCER2Cleared 510(K)
- K915696INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE2Cleared 510(K)
- K915647DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC2502Cleared 510(K)
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- K862686KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM2Cleared 510(K)
- K855247INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER2Cleared 510(K)
- K863700RT2800(115V)/H4008C AND RT2800(220/240V)/H4008CE2Cleared 510(K)
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- K860235MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER2Cleared 510(K)
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- K8447726.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU2Cleared 510(K)
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- K852947ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M2Cleared 510(K)
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- K853755ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-4102Cleared 510(K)
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- K844031SONOMED TECH OPHTHALMIC B-SCAN B-30002Cleared 510(K)
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- K850422ATS ACOUSTIC STANDOFF - WATER BAG2Cleared 510(K)
- K843573CIVCO-SUPER SCAN/BIOPSY GUIDE2Cleared 510(K)
- K833224BIFOCAL 3.0MHZ2Cleared 510(K)
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- K8129293.5 MHZ BIOPSY TRANSDUCER2Cleared 510(K)
- K812301VARIABLE FOCUS 3.5 MHZ TRANSDUCER2Cleared 510(K)
- K811843BIOPSY TRANSDUCER2Cleared 510(K)
- K8107487.5 MHZ WP TRANSDUCER2Cleared 510(K)
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- K802438MARK V DUPLEX ULTRASONIC SCAN SYS.2Cleared 510(K)
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- ITYAssembly, Tube Housing, X-Ray, Diagnostic1Product Code
- IWNCassette, Measurement, Ardran-Crooks1Product Code
- IWYHolder, Head, Radiographic1Product Code
- IWZFilm, Radiographic1Product Code
- IXACassette, Radiographic Film2Product Code
- IXCIlluminator, Radiographic-Film1Product Code
- IXDSource, Calibration, Sealed, Nuclear1Product Code
- IXFTest-Pattern, Radiographic1Product Code
- IXGPhantom, Anthropomorphic, Radiographic1Product Code
- IXHCamera, Focal Spot, Radiographic1Product Code
- IXJGrid, Radiographic1Product Code
- IXKSystem, Imaging, X-Ray, Electrostatic2Product Code
- IXLDevice, Spot-Film2Product Code
- IXOSynchronizer, Ecg / Respirator, Radiographic1Product Code
- IXQTable, Radiographic, Stationary Top2Product Code
- IXRTable, Radiographic, Tilting2Product Code
- IXWProcessor, Radiographic-Film, Automatic2Product Code
- IXXProcessor, Cine Film2Product Code
- IXYHolder, Radiographic Cassette, Wall-Mounted1Product Code
- IYBTube Mount, X-Ray, Diagnostic1Product Code
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2Product Code
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic2Product Code
- IYPPhantom, Anthropomorphic, Nuclear1Product Code
- IYQPhantom, Flood Source, Nuclear1Product Code
- IYTSystem, Rebreathing, Radionuclide2Product Code
- IYWScanner, Rectilinear, Nuclear1Product Code
- IYXCamera, Scintillation (Gamma)1Product Code
- IYYSynchronizer, Electrocardiograph, Nuclear1Product Code
- IYZBed, Scanning, Nuclear1Product Code
- IZCCamera, Positron1Product Code
- IZDProbe, Uptake, Nuclear1Product Code
- IZFSystem, X-Ray, Tomographic2Product Code
- IZGSystem, X-Ray, Photofluorographic2Product Code
- IZHSystem, X-Ray, Mammographic2Product Code
- IZISystem, X-Ray, Angiographic2Product Code
- IZJCamera, X-Ray, Fluorographic, Cine Or Spot2Product Code
- IZLSystem, X-Ray, Mobile2Product Code
- IZOGenerator, High-Voltage, X-Ray, Diagnostic1Product Code
- IZPProgrammer, Changer, Film/Cassette, Radiographic2Product Code
- IZSAperture, Radiographic2Product Code
- IZTCone, Radiographic2Product Code
- IZWCollimator, Automatic, Radiographic2Product Code
- IZXCollimator, Manual, Radiographic2Product Code
- IZZTable, Radiographic, Non-Tilting, Powered2Product Code
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified2Product Code
- JABSystem, X-Ray, Fluoroscopic, Non-Image-Intensified2Product Code
- JACSystem, X-Ray, Film Marking, Radiographic1Product Code
- JAFMonitor, Ultrasonic, Nonfetal2Product Code
- JAGIlluminator, Radiographic-Film, Explosion-Proof1Product Code
- JAKSystem, X-Ray, Tomography, Computed2Product Code
- JAMScanner, Whole Body, Nuclear1Product Code
- JANCounter, Whole Body, Nuclear1Product Code
- JAOScanner, Fluorescent2Product Code
- JARPhantom, Test-Pattern, Radionuclide1Product Code
- JWMSystem, Tomographic, Nuclear2Product Code
- KGIDensitometer, Bone2Product Code
- KPRSystem, X-Ray, Stationary2Product Code
- KPSSystem, Tomography, Computed, Emission2Product Code
- KPTCalibrator, Dose, Radionuclide2Product Code
- KPWDevice, Beam Limiting, X-Ray, Diagnostic2Product Code
- KPXChanger, Radiographic Film/Cassette2Product Code
- KXHCradle, Patient, Radiologic1Product Code
- KXJTable, Radiologic2Product Code
- LEKTransilluminator (Diaphanoscope)3Product Code
- LHOInstrument, Quality-Assurance, Radiologic1Product Code
- LLZSystem, Image Processing, Radiological2Product Code
- LMADigitizer, Image, Radiological2Product Code
- LMBDevice, Digital Image Storage, Radiological1Product Code
- LMCCamera, Multi Format, Radiological2Product Code
- LMDSystem, Digital Image Communications, Radiological1Product Code
- LNHSystem, Nuclear Magnetic Resonance Imaging2Product Code
- LNISystem, Nuclear Magnetic Resonance Spectroscopic2Product Code
- LQAMedia, Reusable Image1Product Code
- MOSCoil, Magnetic Resonance, Specialty2Product Code
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2Product Code
- MUABone Sonometer2Product Code
- MUEFull Field Digital, System, X-Ray, Mammographic2Product Code
- MUIMedia, Coupling, Ultrasound2Product Code
- MWPCabinet, X-Ray System2Product Code
- MYNAnalyzer, Medical Image2Product Code
- NCSSystem, Imaging, Holography, Acoustic2Product Code
- NWEColon Computed Tomography System, Computer Aided Detection2Product Code
- OASX-Ray, Tomography, Computed, Dental2Product Code
- OEBLung Computed Tomography System, Computer-Aided Detection2Product Code
- OIIArthrogram Tray2Product Code
- OIJBiopsy Needle Guide Kit2Product Code
- OIKRadiology Dental Tray2Product Code
- OILDiscography Kit2Product Code
- OIMMri Disposable Kit2Product Code
- OIORadiographic Contrast Tray2Product Code
- OIPRadiology-Diagnostic Kit2Product Code
- OMJChest X-Ray Computer Aided Detection2Product Code
- OQQDiagnostic Ultrasonic Transducer, Robotic2Product Code
- OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance2Product Code
- OWBInterventional Fluoroscopic X-Ray System2Product Code
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile2Product Code
- PGYDisplay, Diagnostic Radiology2Product Code
- POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2Product Code
- QASRadiological Computer-Assisted Triage And Notification Software2Product Code
- QFMRadiological Computer-Assisted Prioritization Software For Lesions2Product Code
- QHAX-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device2Product Code
- QHXFluoroscopic X-Ray Image Intensifier1Product Code
- QHYSolid State Fluoroscopic X-Ray Imager2Product Code
- QIHAutomated Radiological Image Processing Software2Product Code
- QKBRadiological Image Processing Software For Radiation Therapy2Product Code
- RCCC-Arm Fluoroscopic X-Ray System2Product Code
- QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation2Product Code
- QXLCabinet, Emission Computed Tomography System2Product Code
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K043425
- 510(k) Type
- Traditional
- Applicant
- SHEATHING TECHNOLOGIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/28/2005
- Days to Decision
- 77 days
- Submission Type
- Summary