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
- 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
- K203509SMART FINDER2Cleared 510(K)
- K202294Affirm Contrast Biopsy2Cleared 510(K)
- K191495Biopsy Positioner2Cleared 510(K)
- K161575Affirm Lateral Arm Upright Biopsy Accessory2Cleared 510(K)
- K161920Comfort Cover2Cleared 510(K)
- K153486Affirm Prone Biopsy System2Cleared 510(K)
- K152038MammoGRIP2Cleared 510(K)
- K123414SPECBOARD JR.2Cleared 510(K)
- K122836AFFIRM BREAST BIOPSY GUIDANCE SYSTEM2Cleared 510(K)
- K113607BIOPSY DIGIT S BIOPSY SL2Cleared 510(K)
- K113284BIOPSY POSITIONER2Cleared 510(K)
- K103512AFFIRM BREAST BIOPSY GUIDANCE SYSTEM2Cleared 510(K)
- K101373EMBRACE2Cleared 510(K)
- K100692DIGITAL SPOT MAMMOGRAPHY SYSTEM2Cleared 510(K)
- K073262BELLA2Cleared 510(K)
- K071787BEMITT, MODEL 00012Cleared 510(K)
- K071542DIGITAL STEREOLOC II2Cleared 510(K)
- K070344LIV BREAST SELF EXAMINATION AID2Cleared 510(K)
- K062039BIOPSY DIGIT-AM2Cleared 510(K)
- K050663TRAXYLOC-1 SYSTEM2Cleared 510(K)
- K042671PLANMED SOPHIE NUANCE CLASSIC2Cleared 510(K)
- K042095MAMMOTEST2Cleared 510(K)
- K040884LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM2Cleared 510(K)
- K040125SENOGRAPHIC STEREO2Cleared 510(K)
- K033202ADVANTAGE PADDLE2Cleared 510(K)
- K031574SQUEEZE-EASE MAMMOGRAPHY CUSHION2Cleared 510(K)
- K030666MULTICARE PLATINUM SYSTEM AND ACCESSORIES2Cleared 510(K)
- K021945PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)2Cleared 510(K)
- K023864PERFORMA STEREO2Cleared 510(K)
- K023229S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE2Cleared 510(K)
- K022275DELTA 32; DELTA 32 TACT2Cleared 510(K)
- K020624BREAST BOLSTER2Cleared 510(K)
- K013656PLANMED SOPHIE & PLANMED SOPHIE CLASSIC2Cleared 510(K)
- K012953GIOTTO IMAGE2Cleared 510(K)
- K013290MODIFIED 650 MAMMOGRAPHY SYSTEM2Cleared 510(K)
- K011987MODIFIED M-IV MAMMOGRAPHY SYSTEM2Cleared 510(K)
- K010792MAMMOGRAPH2Cleared 510(K)
- K010116PLANMED SOPHIE, PLANMED SOPHIE CLASSIC2Cleared 510(K)
- K003795BIOLUCENT MAMMOGRAPHY CUSHION2Cleared 510(K)
- K003945OPDIMA2Cleared 510(K)
- K002472DELTA 32 AND DELTA 32 TACT2Cleared 510(K)
- K003473DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM2Cleared 510(K)
- K000976DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)2Cleared 510(K)
- K001171DELTA 16 TACT2Cleared 510(K)
- K993681DIGITEC TWO STAGE COMPRESSION KIT2Cleared 510(K)
- K993740MAMEX2Cleared 510(K)
- K992280LORAD 1-650 (INTERNATIONAL 650)2Cleared 510(K)
- K991826PLANMED SOPHIE AND SOPHIE CLASSIC2Cleared 510(K)
- K992037MAMEX2Cleared 510(K)
- K990192BIOPSY-DIGIT2Cleared 510(K)
- K984091CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 20002Cleared 510(K)
- K984092PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-20002Cleared 510(K)
- K983313ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY2Cleared 510(K)
- K983659PLANMED SOPHIE & PLANNED SOPHIE CLASSIC2Cleared 510(K)
- K983621NEEDLE GUIDE2Cleared 510(K)
- K981641MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ2Cleared 510(K)
- K982049BIOPSY M2Cleared 510(K)
- K981470WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE2Cleared 510(K)
- K980235REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)2Cleared 510(K)
- K973631LORAD M-III ELITE (M-III E)2Cleared 510(K)
- K973856GIOTTO HT2Cleared 510(K)
- K973915INFLATABLE POSITIONING CUSHIONS2Cleared 510(K)
- K973493PLANMED CYTOGUIDE2Cleared 510(K)
- K973400MAMMOTEST ADAPTER DRIVER2Cleared 510(K)
- K970680GLORY2Cleared 510(K)
- K964069DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K953902GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM2Cleared 510(K)
- K962105PLANNED SOPHIED CLASSIC2Cleared 510(K)
- K964576PROFILE MAMMOGRAPHY SYSTEM (M-PRO)2Cleared 510(K)
- K961849THE ROBOGUIDE2Cleared 510(K)
- K960381MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION2Cleared 510(K)
- K955411DELTA 162Cleared 510(K)
- K953250SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE2Cleared 510(K)
- K955249SENSOR PAD2Cleared 510(K)
- K954521MAMMOSPOT PADDLE2Cleared 510(K)
- K952210LORAD STEROLOC II2Cleared 510(K)
- K951883PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT2Cleared 510(K)
- K941191REAL TIME STEREOTIX2Cleared 510(K)
- K944978BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI2Cleared 510(K)
- K945962BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY2Cleared 510(K)
- K945743PREFERENCE MAMMOGRAPHY SYSTEM2Cleared 510(K)
- K945241LORAD M-IV, LORAD M-IVI2Cleared 510(K)
- K941353MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM2Cleared 510(K)
- K945619ATHENA HFX2Cleared 510(K)
- K950608DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION2Cleared 510(K)
- K944816SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)2Cleared 510(K)
- K932356NOVA XM22Cleared 510(K)
- K934478ALPHA STEREO2Cleared 510(K)
- K945496MAMMOGRAPHIC X-RAY UNIT2Cleared 510(K)
- K945272RHODIUM FILTER2Cleared 510(K)
- K935428BENNETT X-RAY DIGITAL SPOT IMAGER2Cleared 510(K)
- K934868LORAD TRANSPO2Cleared 510(K)
- K933430CYTOGUIDE STEREOTATIC BIOPSY SYSTEM2Cleared 510(K)
- K932672MAMMOMAT 300 AND MAMMOMAT 30002Cleared 510(K)
- K934831ADVANCED AUTOMATIC KV2Cleared 510(K)
- K935608MAMOSPAT2Cleared 510(K)
- K936161SYSTEM, X-RAY, MAMOGRAPHIC2Cleared 510(K)
- K940701BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH2Cleared 510(K)
- K934373MOBILE SOPHIE MODIFICATION2Cleared 510(K)
- K934870LORAD D-5502Cleared 510(K)
- K934748LORAD M-IIE MODIFICATION2Cleared 510(K)
- K934625LORAD M-III2Cleared 510(K)
- K933754CHENOWETH-FRANK RADIOPATHOLOGICAL GRID2Cleared 510(K)
- K930282AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS2Cleared 510(K)
- K925725CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR2Cleared 510(K)
- K925212GIOTTO PATIENT BED2Cleared 510(K)
- K923471PLANMED CYTOGUIDE2Cleared 510(K)
- K921962LORAD DIGITAL SPOT MAMMOGRAPHY2Cleared 510(K)
- K921986PATIENT INFORMATION MANAGER (PIM)2Cleared 510(K)
- K922454MOBILE ATHENA HF2Cleared 510(K)
- K923061MAMMOSCAN2Cleared 510(K)
- K920470MEYER FOREIGN BODY LOCATOR2Cleared 510(K)
- K921896TILTING MAG2Cleared 510(K)
- K915201CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO2Cleared 510(K)
- K922619DIGITIZER, MODEL # 3-000A-15182Cleared 510(K)
- K920938VJW2919 PNEUMATIC COMPRESSION UPGRADE2Cleared 510(K)
- K915748AVIVA MAMMOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K913732MAMMOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K913418SENOGRAPHE DMR/SMR/DM2Cleared 510(K)
- K913845PHILIPS MAMMODIAGNOST BC2Cleared 510(K)
- K914328MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K910111VARIOUS MODELS OF DAYLIGHT CASSETTE HOLDERS2Cleared 510(K)
- K912974MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K896596ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL2Cleared 510(K)
- K904953PLANMED SOPHIE2Cleared 510(K)
- K905748MAMEX DC AMI SL12/MG152Cleared 510(K)
- K904517MAMMOSPOT 3 AND MAMMOSPOT 82Cleared 510(K)
- K903651AMI MAMMOSPOT2Cleared 510(K)
- K901558GIOTTO MAMMOGRAPHY HF2Cleared 510(K)
- K901997X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS2Cleared 510(K)
- K900989ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K896609CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC2Cleared 510(K)
- K892342TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM2Cleared 510(K)
- K884107STEREOTACTIC BIOPSY ATTACHMENT2Cleared 510(K)
- K890784MAMMOMAT C2Cleared 510(K)
- K885020CYTOGUIDE2Cleared 510(K)
- K891090SPECBOARD2Cleared 510(K)
- K884345MODEL ESP-200 MAMMOGRAPHIC SYSTEM2Cleared 510(K)
- K890483THE PATHFINDER SYSTEM2Cleared 510(K)
- K885135MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-1502Cleared 510(K)
- K884917RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM2Cleared 510(K)
- K884676MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.2Cleared 510(K)
- K884677MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.2Cleared 510(K)
- K882875STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY2Cleared 510(K)
- K882133MAMMO M2Cleared 510(K)
- K881697BREAST LESION LOCALIZATION NEEDLE2Cleared 510(K)
- K881506MAMEX DC MAG MG122Cleared 510(K)
- K881505MAMEX DC MG112Cleared 510(K)
- K881882SENOGRAPHE 600T AND 600TS SENIX HF2Cleared 510(K)
- K880531MAMMOGRAPHIC X-RAY SYSTEM ATHENA2Cleared 510(K)
- K880905MAMMOGRAPHY MOVING GRID BUCKY2Cleared 510(K)
- K875377SHIMADZU MAMMOGRAPHIC STAND MR-302Cleared 510(K)
- K874040MAMEX DC S SL10/MG142Cleared 510(K)
- K873618STEREOTIX2Cleared 510(K)
- K873836MAMMOGRAPHIC KVP METER MODEL 2322Cleared 510(K)
- K872734MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE2Cleared 510(K)
- K871048MICRO MAMMO I MAMMOGRAPHY UNIT2Cleared 510(K)
- K872980MAM-CP X-RAY APPARATUS2Cleared 510(K)
- K871592RF-1 CIRCUIT2Cleared 510(K)
- K864958ALPHA II DIAGNOSTIC X-RAY2Cleared 510(K)
- K861692FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM2Cleared 510(K)
- K863710ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT2Cleared 510(K)
- K860129ISO-MAMMO2Cleared 510(K)
- K854203TEC 2720 MAMEX DC MAG2Cleared 510(K)
- K854510MINXRAY 500M MAMMOGRAPHIC SYSTEM2Cleared 510(K)
- K853395RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-10002Cleared 510(K)
- K844119MAMMOGRAPH III2Cleared 510(K)
- K850173AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT2Cleared 510(K)
- K850614SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY2Cleared 510(K)
- K843437MEI MAMMOGRAPHY SYS MX-20492Cleared 510(K)
- K842102LORAD2Cleared 510(K)
- K841774UNIMACS, PATENT PENDING UNIVERSAL MAM2Cleared 510(K)
- K833243MAMMOGRAPHIC S-RAY SYSTEM2Cleared 510(K)
- K832733XEROX 120 SYS MAMMOGRAPHIC X-RAY2Cleared 510(K)
- K790273MAMMOGRAPHY SYSTEM AND CASSETTE2Cleared 510(K)
- K770693X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC2Cleared 510(K)
- 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
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K010116
- 510(k) Type
- Traditional
- Applicant
- PLANMED OY
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/15/2001
- Days to Decision
- 58 days
- Submission Type
- Statement