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
- QRNRadiation Therapy Marking Device2Product Code
- KTAMedium, Contrast, RadiologicUProduct Code
- LMZApplicator, Hyperthermia, Interstitial3Product Code
- LNBApplicator, Hyperthermia, Deep Heating, Ultrasound3Product Code
- LNCApplicator, Hyperthermia, Superficial, Rf/Microwave3Product Code
- LOCSystem, Rf/Microwave Hyperthermia, Cancer Treatment3Product Code
- LSYUltrasound, Hyperthermia, Cancer Treatment3Product Code
- MJSContrast Media, Ultrasound3Product Code
- MOTIrradiator, Blood To Prevent Graft Versus Host DiseaseUProduct Code
- NANTester, Acoustic, Bone Quality3Product Code
- NAWMicrospheres Radionuclide3Product Code
- NCLImager, Breast, Electrical Impedance3Product Code
- OLQCross-Sectional Mammographic Xray System3Product Code
- OTEDigital Breast Tomosynthesis3Product Code
- PAAAutomated Breast Ultrasound3Product Code
- QNKOptoacoustic Imaging System3Product Code
- QUVPhase-Changing Fiducial Marker For Radiation Therapy2Product Code
- QVAFludeoxyglucose F18-Guided Radiation Therapy System2Product Code
- QVDRadiological Machine Learning Based Quantitative Imaging Software With Change Control Plan2Product Code
- QXRVaginal Hydrogel Packing System2Product Code
- QVWGenerator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-LedNProduct Code
- QZLPost-Ablation Tissue Response Prediction Software2Product Code
- QWORadiology Software For Referral Of Findings Related To Fibrotic Lung Disease.2Product Code
- SAORadiology Software For Opportunistic Evaluation Of Low Bone Mineral Density2Product Code
- SEZRadiological Software Device To Predict Future Breast Cancer Risk2Product Code
- SGJUltrasound Imaging System For Acquiring Images At Home By Lay Users2Product Code
- Submissions with No Product CodeMiscellaneous
- K250392ZAP-X Radiosurgery System (ZAP-X)Cleared 510(K)
- K904722FLUOROSCOPIC TABLE, TILT OR POWER TILTING MED. TABCleared 510(K)
- K862643RADIATION ONCOLOGY COMPUTER SYS TREATMENT PLANNINGCleared 510(K)
- K870205ROTAX-II BI-PLANE CIRCULAR ARMCleared 510(K)
- K862593DAS 211Cleared 510(K)
- K850207PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RULCleared 510(K)
- K841048TRANSDUCER 4.OMHZ LA4011Cleared 510(K)
- K828543UNKNOWNCleared 510(K)
- K843985SUSPENSION 7Cleared 510(K)
- K842599METER MOUSE SYSTEMCleared 510(K)
- K833235KODAK MULTILOADER II FOR X-OMATIC CASSCleared 510(K)
- K837573SHARPLAN LASER POSITIONING SYSTEMCleared 510(K)
- K837605MV/CM2 NUMBER X74294 MODEL NUMBER 74229Cleared 510(K)
- K837465ALCYON ROTATIONAL COBALT THERAPYCleared 510(K)
- K837355UNKNOWNCleared 510(K)
- K837515DENTAL CASSETTE HOLDERSCleared 510(K)
- K837412SATURNE I LINEAR ACCELERATORCleared 510(K)
- K837608PIP X-RAY PROTECTIVE GLASSESCleared 510(K)
- K837481BF24 DOPPLER MODEL P872 AND P874Cleared 510(K)
- K837346MODEL GAMMACELL 1000Cleared 510(K)
- K837517INFRADIODE INFRARED LAMPCleared 510(K)
- K837494BABY LIGHT METERCleared 510(K)
- K837513UNKNOWNCleared 510(K)
- K837491REX PEDESTAL INTRA-ORAL X-RAY UNITCleared 510(K)
- K837506KODAK T-MAT G FILM SO-381Cleared 510(K)
- K837499AUTOSECTORCleared 510(K)
- K837443OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHYCleared 510(K)
- K837422LASER PHOTOCOAGULATORCleared 510(K)
- K837413STRETCHER TOP TSI-107Cleared 510(K)
- K837440UNKNOWNCleared 510(K)
- K837329SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUNDCleared 510(K)
- K837343PZ-600 COMPUTERIZED AXIAL TOMOGRAPHY SCANNERCleared 510(K)
- K837230MODEL ND1100 BONE DENSITY SCANNERCleared 510(K)
- K837430AUTO D OPTIONCleared 510(K)
- K837378OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEMCleared 510(K)
- K837342SHARPLAN 721 CO2 SURGICAL LASERCleared 510(K)
- K837085DOPPLER FOR DETECTING OCCLUSIONS AND TAKING SYSTOLIC BLOOD PRESSURECleared 510(K)
- K837344BEAM BLOCK SHAPERCleared 510(K)
- K837304MODELS 246 AND 210F LINEAR ARRAY ULTRASOUND SCANNERCleared 510(K)
- K837331CORNEOMAP 4500 ULTRASOUND MEASUREMENTCleared 510(K)
- K837382OPTISON ULTRASONIC SCALERCleared 510(K)
- K837224UNKNOWNCleared 510(K)
- K837336VERASUN RADIATION THERAPY SIMULATION SYSTEMCleared 510(K)
- K837314SDL-10 DIAGNOSTIC ULTRASOUNDCleared 510(K)
- K837245TRANSPARENT X-RAY COMPENSATION FILTERCleared 510(K)
- K837084ULTRASOUND EQUIPMENT MODEL SDL-100ACleared 510(K)
- K828562DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTECleared 510(K)
- K837282MODEL VPS VASCULAR PROFILE SYSTEMCleared 510(K)
- K837334X-RAY BEAM FILTERCleared 510(K)
- K837351EXOSCOPE LS-53Cleared 510(K)
- K837354POWERED MOBILE BASE FOR 200MM AND 300MM SIZE DETECTORSCleared 510(K)
- K837322NOVO CEREBROGRAPHCleared 510(K)
- K837306LASER PHOTOCOAGULATORCleared 510(K)
- K837278UWE SUN STREAM UWE BERMUDA UWE SUPER NOVA AND UWE BRONZARETTECleared 510(K)
- K837283UNKNOWNCleared 510(K)
- K837229TRANSDUCER MODELS 450, 451, 452, 453, 454Cleared 510(K)
- K837353FLOATEX LS-22Cleared 510(K)
- K837352CEILEX LS-15/ALLMEC ARGOSTATCleared 510(K)
- K827708ULTRASONIC MEDICAL DEVICE MODEL 3 LO 4Cleared 510(K)
- K837202KODAK ORTHO C FILM SO-344Cleared 510(K)
- K837201KODAK LANEX FAST SCREENS SO-470Cleared 510(K)
- K837252DIGITAL SUBTRACTION ANGIOGRPAHYCleared 510(K)
- K837235MODEL 920 ARGON LASER SYSTEMCleared 510(K)
- K828574NOVO BMC LAB 22A BONE MINERAL CONTENT DETERMINATION IN THE AXIAL SKELETONCleared 510(K)
- K837216MODEL XA-15 LASER SYSTEM FOR SURGERYCleared 510(K)
- K837213MULTI-USER IMAGING AND ACQUISITION TERMINALSCleared 510(K)
- K837200BRITT SURGICAL PHOTOCOAGULATOR SYSTEMCleared 510(K)
- K837063BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEMCleared 510(K)
- K837181EMINEX LS-8 SYSTEMCleared 510(K)
- K837046AUTOFOCUS PROBE FOR USE WITH ULTRASOUND AUTOSECTOR SYSTEMCleared 510(K)
- K837100DIGITIZING COLORIZING APPLE COMPUTER SYSTEM FOR RE-VIEW OF NORMAL ROENTGEN FILMCleared 510(K)
- K837142TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEMCleared 510(K)
- K837178STANDEX SYSTEMCleared 510(K)
- K8370972D CARDIAC SECTOR SCANNERCleared 510(K)
- K837151BLUE GREEN FILTER SYSTEM TO MODEL 152 AND 150 LASER SYSTEMCleared 510(K)
- K837109UNKNOWNCleared 510(K)
- K837106ELDER PSORALITE SERIES 2000 UVA IRRADIATION SYSTEMCleared 510(K)
- K837108ULTRAVIOLET ELDER PSORALITE SERIES 3000 UVACleared 510(K)
- K837029ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICECleared 510(K)
- K837183HI-LO RADIOLOGICAL STRETCHERCleared 510(K)
- K837176EXOR LS-24Cleared 510(K)
- K837175ARMEX LS-51Cleared 510(K)
- K837171ULTRASONIC ECHOSCOPECleared 510(K)
- K837179TAURUS LS THREE-PHASE GENERATORSCleared 510(K)
- K837180TREPHIX THREE PHSE GENERATORS AND EXONON SINGLE PHASE GENERATORSCleared 510(K)
- K837182TOMAX LS-20Cleared 510(K)
- K837177CONTROLLEX LS-5Cleared 510(K)
- K837102MODEL 2100 FETAL MONITORCleared 510(K)
- K837110MODEL 4100 MICROSURGICAL CO2 LASER SYSTEMCleared 510(K)
- K8371173M FERLIC CHEST FILTER, X-RAY COMPENSATING FILTERCleared 510(K)
- K837107SOMATOM DRI X-RAY CT SCANNERCleared 510(K)
- K837081MICROSCAN 771 MANIPULATORCleared 510(K)
- K837111X RAY TUBE HOUSING/INSERTCleared 510(K)
- K837033ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440Cleared 510(K)
- K837028PARKINSON NEUROSURGICAL HEADCLAMP FOR SERIAL ANGIOGRAPHYCleared 510(K)
- K837105ELDER PSORALITE, SERIES 43000Cleared 510(K)
- K837125SYSTEM 900 TWO ROOM REMOTE FIBERSCleared 510(K)
- K828326UNKNOWNCleared 510(K)
- K837139MODELS EUROSUN 2400 AND 800Cleared 510(K)
- K828328ULTRASCAN DIGITAL A/SYSTEM IIICleared 510(K)
- K827346SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNITCleared 510(K)
- K837032UVB LIGHT BOX TANNING BOOTHCleared 510(K)
- K827577VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETERCleared 510(K)
- K837030MODEL ML-4000 OPHTHALMIC LASER WITH FIBER OPTIC DELIVERY SYSTEMCleared 510(K)
- K828671UVATEC SUNTAMED 4000 AND 2000Cleared 510(K)
- K828673RICH-MAR ULTRASOUND COUPLING LOTIONCleared 510(K)
- K828676DERMALIGHT SPOTCleared 510(K)
- K828675DERMALIGHT UVASTAR 400Cleared 510(K)
- K828674DERMALIGHT BLUE-POINTCleared 510(K)
- K828670UVATEC SUNTAMED 400Cleared 510(K)
- K828661BARIUM ENEMASCleared 510(K)
- K828669COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100Cleared 510(K)
- K828583LASERMED OCULASE ARGON LASERCleared 510(K)
- K828621VIDEO IMAGE PROCESSORCleared 510(K)
- K827819LASER PHOTOCOAGULATORCleared 510(K)
- K828056MODEL 716 MICROMANIPULATORCleared 510(K)
- K828606MODEL PDX-4800 PROJECTION DIGITAL X-RAY SYSTEMCleared 510(K)
- K828605BEAM LIMITING DEVICECleared 510(K)
- K828585OPTHALAS PHOTOCOAGULATORCleared 510(K)
- K828619OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520MCleared 510(K)
- K828654UVB CABINET OR GOEKERMAN CABINET, MODEL SPECTRA 305Cleared 510(K)
- K827847ARGON FIBER OPTIC CATHETERCleared 510(K)
- K828575F-100 FLUOROSCOPIC CONTROL AND XF-100 HIGH VOLTAGE GENERATORCleared 510(K)
- K828566VIDIVIEWER MOTORIZED MASS FILM VIEWERCleared 510(K)
- K828565BRATTLE R-DETECT PHYSIOLOGICAL SYNCHRONIZERSCleared 510(K)
- K828564COMPUTER DATA MONITORING SYSTEMCleared 510(K)
- K828620MULTI IMAGE CAMERACleared 510(K)
- K828545MAXICAMERA 500A SMALL FIELD IMAGING SYSTEMCleared 510(K)
- K828544MAXICAMERA 400ZSCleared 510(K)
- K828586ENTREKIN MODEL DX-300 CONTINUOUS WAVE ULTRASONIC DOPPLER TRANSDUCERCleared 510(K)
- K827176MODEL 640 LINEAR SCANNERCleared 510(K)
- K828595MAXICAMERA 300A SMALL FIELD OF VIEW IMAGING SYSTEMCleared 510(K)
- K827383MODEL 900 PHOTOCOAGULATOR WITH GREEN-ONLY OPTIONSCleared 510(K)
- K828325YOSHIDA/KAYCOR X-70 X-RAY UNITCleared 510(K)
- K828313DIGITAL RADIOGRAPHY EXAMINATION TABLECleared 510(K)
- K827744DYNEX ULTRASOUND DIAGNOSTIC SCANNERCleared 510(K)
- K827704MM-22 MICROTRONCleared 510(K)
- K827690SPECTRA MINI, ULTRAVIOLET EMITTER FOR DERMATOLOGICAL USECleared 510(K)
- K827098SUNROOF SUNLAMPCleared 510(K)
- K828194LASER LAPAROSCOPECleared 510(K)
- K827408ULTRA IMAGERCleared 510(K)
- K828249MODEL 4045 RADIONUCLIDE CALIBRATORCleared 510(K)
- K828053ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCERCleared 510(K)
- K828051ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LCCleared 510(K)
- K828050ADR ULTRASOUND MODEL 4000 LCleared 510(K)
- K828049ADR ULTRASOUND MC2 LARGE CARTCleared 510(K)
- K828055MAMMOMAT B AND BECleared 510(K)
- K827891ULTRASONIC PULSED ECHO IMAGING SYSTEM RT30Cleared 510(K)
- K827454UNKNOWNCleared 510(K)
- K828054UV-A AND UV-B FLUORESCENT LAMPSCleared 510(K)
- K827993MTH C/A MOBILE C ARMCleared 510(K)
- K827963MODEL ML-850Cleared 510(K)
- K827929MOBILETT, MOBILE X-RAY UNITCleared 510(K)
- K827913NIIC CO2 LASER SYSTEM MODEL 6OZ.Cleared 510(K)
- K827914NIIC CO2 LASER SYSTEM MODEL 3OZ.Cleared 510(K)
- K827861INTROSPEC A-10Cleared 510(K)
- K827889KODAK KODAFLEX FILMCleared 510(K)
- K827453UV SAFETY INFUSER SHIELDCleared 510(K)
- K827858MODEL 835 SPOT FILM DEVICECleared 510(K)
- K827796INNOSCAN EXAMINATION LIGHTCleared 510(K)
- K827815SONOLINE 6000Cleared 510(K)
- K827816PODIATRY X-RAY UNITCleared 510(K)
- K827818DOPPLER FLOW METER, LASERCleared 510(K)
- K827503SONOLINE 1000, 8008 AND 8080Cleared 510(K)
- K827792SIREMOBILE 3Cleared 510(K)
- K827573DIASONICS CARDIO/IMAGING ECHOSCOPECleared 510(K)
- K827748THYRO-COUNT THYROID UPTAKE SYSTEM 90IZD PROBECleared 510(K)
- K827663SINUSON 810 ULTRASOUND SCANNERCleared 510(K)
- K827662AUTO-TECH GENERATORCleared 510(K)
- K827718UNKNOWNCleared 510(K)
- K827712LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIESCleared 510(K)
- K827760DIGITAL FLUOROGRAPHIC X-RAY SYSTEMCleared 510(K)
- K827762RADIOGRAPHIC FILM ILLUMINATORCleared 510(K)
- K827761MED-X MODEL 301 X-RAY FILTERCleared 510(K)
- K827713SCANNER 560 ULTRASOUND SCANNERCleared 510(K)
- K827286MODEL 8000 SECTOR IMAGER SYSTEMCleared 510(K)
- K827287MODEL 8100 SECTOR IMAGERCleared 510(K)
- K827666SUNTANNING BOOTHCleared 510(K)
- K827644DELTASCAN HPS CT SCANNERCleared 510(K)
- K827607MODEL 712 MICROMANIPULATORCleared 510(K)
- K827035OCULAR BIOMETER 4000Cleared 510(K)
- K827652TECHNICARE ULTRASOUND AUTO SECTOR B-SCAN ARM OPTIONCleared 510(K)
- K827610ULTRASOUND AUTO SECTOR CARDIAC MODULECleared 510(K)
- K827584JAPANESE MADE MICROWAVE THERAPY EQUIPMENTCleared 510(K)
- K827377MODEL LS 3000 LINEAR SCANNERCleared 510(K)
- K827609MIDWEST AUTOMATIC BUCKY EQUIPPED WITH GRID AND SIZE-O-MATIC TRAYCleared 510(K)
- K827292MODEL IC 3000Cleared 510(K)
- K827571MOBILE DIGITAL RECEPTORCleared 510(K)
- K827572ADAC MODEL DPS-6100 MULTI MODALITY DIGITAL PROCESING SYSTEMSCleared 510(K)
- K827582MODIFIED X-RAY TABLECleared 510(K)
- K827543MAXICAMERA MODEL 200ACleared 510(K)
- K827409REAL TIME ULTRASOUND SCANNER 1849Cleared 510(K)
- K827380SCANNER TYPE 1846Cleared 510(K)
- K827371CILCO ASCANCleared 510(K)
- K827455SONOLINE 3000Cleared 510(K)
- K827580ADAC MODEL DPS-3300 DIGITAL PROCESSING SYSTEMCleared 510(K)
- K827581ADAC MODEL DPS-2800 DIGITAL PROCESSING SYSTEMCleared 510(K)
- K827375BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000ACleared 510(K)
- K827376BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 800Cleared 510(K)
- K827508ULTRASONIC CLEANERCleared 510(K)
- K827370IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEMCleared 510(K)
- K827525AUTOMATIC EXPOSURE CONTROL TYPE A3300Cleared 510(K)
- K827470STATIONARY SPECIAL PURPOSE PODIATRY X-RAY UNITCleared 510(K)
- K827506MODEL ML-820 CARBON DIOXIDE LASER SYSTEM FOR SURGERYCleared 510(K)
- K827501MODEL 580 DIGITAL RADIOGRAPHY SYSTEMCleared 510(K)
- K827504SIZE SENSING CASSETTE TRAYCleared 510(K)
- K827502MODEL DPS-4050 DIGITAL RADIOGRAPHY SYSTEMCleared 510(K)
- K827410LITERATURE ON THE SONADENTCleared 510(K)
- K827507ENDOSCOPIC ACCESSORY U/S/ CLEANING MACHINECleared 510(K)
- K827450SIMPLAMATIC IIICleared 510(K)
- K827448BSINUS DIAPHANOGRAPHCleared 510(K)
- K827378DIAGNOSTIC X-RAY HV GENERATORCleared 510(K)
- K827379X-RAY CASSETTECleared 510(K)
- K827442ML-810 CARBON DIOXIDE LASER SYSTEMCleared 510(K)
- K827345VHR VIDEO SYSTEMCleared 510(K)
- K827177LTRASONIC SCANNER U.S. ALOKA SSD-500Cleared 510(K)
- K827291MODEL PUP II AND MINI-NEBULIZERCleared 510(K)
- K827288MLX LATERAL IMAGING SYSTEMCleared 510(K)
- K827284MODEL SSD-119Cleared 510(K)
- K827285MODEL SSD-710Cleared 510(K)
- K827289DIGITAL RADIOGRAPHY SYSTEMCleared 510(K)
- K827209SYSTEM 287 SCANNERCleared 510(K)
- K827175ARS-1000 RADIATION THERAPY TREATMENT PLANNING SYSTEMCleared 510(K)
- K827122DELTA PLAN II RADIATION THERAPY PLANNING SYSTEMCleared 510(K)
- K827036AUTO SECTOR MCUCleared 510(K)
- K827124RALCO COLLIMATOR, AUTOMATIC, RADIOGRAPHICCleared 510(K)
- K827126TECHNOMED GENERATOR, RADIOGRAPHIC, 3 PHASECleared 510(K)
- K827123SPECTRA (ULTRAVIOLET PRODUCTS)Cleared 510(K)
- K827125RALCO COLLIMATORS, MANUAL, RADIOGRAPHICCleared 510(K)
- K827087P1808 MOBILE C-ARM IMAGE INTENSIFIERCleared 510(K)
- K827104ADDITIONAL TERMINAL SUPPORT FOR STAR TM BASIC SYSTEMCleared 510(K)
- K827086LATERAL ANGULATING FLUORO SUSPENSIONCleared 510(K)
- K827064SIEMENS POLYDOROS 800Cleared 510(K)
- K827034INTELECT MODEL 200Cleared 510(K)
- K827033INTELECT MODEL 700Cleared 510(K)
- K827069PODIOSCOPE BY ARROWCleared 510(K)
- K827065SIEMENS SIRESKOP 4Cleared 510(K)
- K812089POLAROID RADIOGRAPHIC FILM CASSETTECleared 510(K)
- K810155DOP 84Cleared 510(K)
- K801149BEL O SOL UVA SUNLAMP DEVICECleared 510(K)
- K801129QUICKTAN BOOTHCleared 510(K)
- K800845BRONZAGE TANNING SYSTEMCleared 510(K)
- K800366SOLARIUM, MODEL 6040ACleared 510(K)
- K800592SUN SCENE TAN BOOTHCleared 510(K)
- K801034TANNING BOOTH/TANS BY TANIQUECleared 510(K)
- K801027MDS IMAGERCleared 510(K)
- K800998ATLAS-S X-RAY SYSTEM W/KETROMAT GEN.Cleared 510(K)
- K800867DOSE CALIBRATION REF. SOURCES; BARIUM-13Cleared 510(K)
- K800835KANDI-NUCLEAR MED. DATA ACQU.&INFO.Cleared 510(K)
- K800697SUNHOUSE UVB ULTRAVIOLET LIGHT TANNINGCleared 510(K)
- K781214CAMERAS, MULTI-IMAGECleared 510(K)
- K781056DIGITAL IMAGE MEMORY/PROCESSORCleared 510(K)
- K780813IDI GDR DATA REDUCTION SYSTEMCleared 510(K)
- K7706151304A X-Y DISPLAY INTRODUCTIONCleared 510(K)
- K770397MONITOR, RADIOISOTOPE, MODEL 9273ACleared 510(K)
- K760083PHYSIOSCOPECleared 510(K)
- Subpart B—Diagnostic DevicesCFR Sub-Part
- 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
MODEL 8100 SECTOR IMAGER
- Page Type
- Cleared 510(K)
- 510(k) Number
- K827287
- 510(k) Type
- Traditional
- Applicant
- OTE BIOMEDICA
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/6/1982
- Days to Decision
- 52 days