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
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- GXDGenerator, Lesion, Radiofrequency2Product Code
- GXELeukotome1Product Code
- GXHDevice, Surgical, Cryogenic2Product Code
- GXIProbe, Radiofrequency Lesion2Product Code
- GXJPunch, Skull1Product Code
- GXLScrewdriver, Skullplate1Product Code
- GXMAnvil, Skull Plate1Product Code
- GYKInstrument, Shunt System Implantation1Product Code
- GZQInstrument, Dowel Cutting2Product Code
- GZTRetractor, Self-Retaining, For Neurosurgery2Product Code
- GZXInstrument, Microsurgical1Product Code
- HADRongeur, Powered2Product Code
- HAERongeur, Manual2Product Code
- HAOInstrument, Surgical, Non-Powered1Product Code
- HASNeedle, Neurosurgical Suture1Product Code
- HAWNeurological Stereotaxic Instrument2Product Code
- HBANeurosurgical Paddie2Product Code
- HBBMotor, Drill, Pneumatic2Product Code
- HBCMotor, Drill, Electric2Product Code
- HBDHandpiece (Brace), Drill1Product Code
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)2Product Code
- HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)2Product Code
- HBGDrills, Burrs, Trephines & Accessories (Manual)2Product Code
- HBLHolder, Head, Neurosurgical (Skull Clamp)2Product Code
- K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)2Cleared 510(K)
- K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)2Cleared 510(K)
- K203505DORO QR3 Headrest System (Aluminum)2Cleared 510(K)
- K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)2Cleared 510(K)
- K191740DORO LUCENT® iXI and iMRI Headrest System2Cleared 510(K)
- K191701Arcus Head Fixation Frame2Cleared 510(K)
- K191979DORO QR3 XTom Headholder System2Cleared 510(K)
- K163322TZ SKULL PIN Adult2Cleared 510(K)
- K142238MAYFIELD Skull Clamp2Cleared 510(K)
- K141950HFD100 ROCKER ARM ACCESSORY2Cleared 510(K)
- K122225STERILE RADIOLUCENT SKULL PINS2Cleared 510(K)
- K130389MAYFIELD INFINITY XR2 SKULL CLAMP2Cleared 510(K)
- K120633MAYFIELD SKULL CLAMP2Cleared 510(K)
- K113748IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)2Cleared 510(K)
- K103493HEAD FIATION DEVICE (HFD 100)2Cleared 510(K)
- K083803FIXIT HEADREST CLAMP SYSTEM2Cleared 510(K)
- K091439HEAD FIXATION ARC AND TABLE BASE2Cleared 510(K)
- K090695DINKLER SURGICAL SKULL CLAMP, MODEL 03082Cleared 510(K)
- K090506MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-21142Cleared 510(K)
- K081401MAYFIELD MR/X-RAY SKULL CLAMP2Cleared 510(K)
- K073163LIMITED ARTIFACT SKULL PIN, MODEL 01072Cleared 510(K)
- K072208MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS2Cleared 510(K)
- K071458MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS2Cleared 510(K)
- K063494DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS2Cleared 510(K)
- K053045MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-20202Cleared 510(K)
- K051440MAYFIELD INFINITY SKULL CLAMP2Cleared 510(K)
- K050319MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-11042Cleared 510(K)
- K032331DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)2Cleared 510(K)
- K031885NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX2Cleared 510(K)
- K021604MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-20202Cleared 510(K)
- K002990VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 220012Cleared 510(K)
- K002276PSI SKULL CLAMP2Cleared 510(K)
- K001808DORO HEADREST SYSTEM2Cleared 510(K)
- K955012MIZUHO RADIOLUCENT HEAD FRAME2Cleared 510(K)
- K953124MAYFIELD RADIOLUCENT 2000 SKULL CLAMP2Cleared 510(K)
- K941558MAYFIELD CHILD DISPOSABLE SKULL PIN2Cleared 510(K)
- K934289MAYFIELD RADIOLUCENT SKULL CLAMP2Cleared 510(K)
- K932860MAYFIELD ADULT DISPOSABLE SKULL PIN2Cleared 510(K)
- K932807MAYFIELD* A-2000 SKULL CLAMP2Cleared 510(K)
- K923789MAYFIELD ADULT DISPOSABLE SKULL PIN2Cleared 510(K)
- K912005CODMAN SKULL PINS (ADULT & CHILD), REUSABLE2Cleared 510(K)
- K911723CODMAN DISPOSABLE SKULL PINS2Cleared 510(K)
- K913170CODMAN SKULL CLAMP2Cleared 510(K)
- K911772GARDNER PINS (ADULT & CHILD)2Cleared 510(K)
- K912011CODMAN SKULL CLAMP2Cleared 510(K)
- K901393MAINZ HEAD FIXATION BY PERNECZKY2Cleared 510(K)
- K893911MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM2Cleared 510(K)
- K874298MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME2Cleared 510(K)
- K821772SURGITA/MIZHO MICRONEUROSURGERY HEAD FR2Cleared 510(K)
- HBMHeadrest, Neurosurgical1Product Code
- HBNChair, Neurosurgical1Product Code
- HBOClip, Scalp2Product Code
- HBQInstrument, Clip Removal1Product Code
- HBRRack, Clip1Product Code
- HBSInstrument, Clip Forming/Cutting1Product Code
- HBXInstrument, Cranioplasty Material Forming1Product Code
- HCACatheter, Ventricular2Product Code
- HCDCannula, Ventricular1Product Code
- HCIApplier, Aneurysm Clip2Product Code
- NHCCatheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)2Product Code
- NLNDrills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed2Product Code
- NLODrills, Burrs, Trephines And Accessories (Manual), Reprocessed2Product Code
- NLPDrills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed2Product Code
- NMNInstrument, Clip, Forming/Cutting, Reprocessed1Product Code
- OJGNeurological Tray1Product Code
- ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative Mri2Product Code
- PIYStainless Steel Instrument, Shunt System Implantation1Product Code
- PPTCranial Surgical Planning And Instrument Guides2Product Code
- PVMEndoscopic Ventricular Catheter Placement Kit2Product Code
- QFXDiagnostic Neurosurgical Microscope Filter2Product Code
- QRISurgical Planning Software For Neurological Stereotaxic Instruments2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K031885
- 510(k) Type
- Traditional
- Applicant
- IMAGE-GUIDED NEUROLOGICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/21/2003
- Days to Decision
- 64 days
- Submission Type
- Statement