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
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- FCDBarium Enema Kit1Product Code
- ITZAssembly, Tube Housing, X-Ray, Therapeutic2Product Code
- IWASource, Wire, Iridium, Radioactive2Product Code
- IWBSystem, Radiation Therapy, Radionuclide2Product Code
- IWDDevice, Beam Limiting, Teletherapy, Radionuclide2Product Code
- IWEMonitor, Patient Position, Light-Beam1Product Code
- IWFNeedle, Isotope, Gold, Titanium, Platinum2Product Code
- IWGSeed, Isotope, Gold, Titanium, Platinum2Product Code
- IWHSource, Teletherapy, Radionuclide1Product Code
- IWISource, Isotope, Sealed, Gold, Titanium, Platinum2Product Code
- IWJSystem, Applicator, Radionuclide, Manual1Product Code
- IWKCyclotron, Medical2Product Code
- IWLSystem, Radiation Therapy, Neutron, Medical2Product Code
- IWMSynchrotron, Medical2Product Code
- IXIBlock, Beam-Shaping, Radiation Therapy2Product Code
- IYCGenerator, Orthovoltage, Therapeutic X-Ray2Product Code
- IYDGenerator, Low Voltage, Therapeutic X-Ray2Product Code
- IYEAccelerator, Linear, Medical2Product Code
- K250696AccuCheck2Cleared 510(K)
- K250911MOSkin Radiation Measurement System2Cleared 510(K)
- K252948TrueBeam, TrueBeam STX, Edge and VitalBeam2Cleared 510(K)
- K252174AquaCast Mask2Cleared 510(K)
- K243142Cranial 4Pi Immobilization2Cleared 510(K)
- K243301MapRT2Cleared 510(K)
- K250099Mobius3D (4.1)2Cleared 510(K)
- K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set2Cleared 510(K)
- K241937Klarity SGRT System (ARSG-E1A, ARSG-E3A)2Cleared 510(K)
- K242957Identify (4.0)2Cleared 510(K)
Show All 722 Submissions
- IYGBetatron, Medical2Product Code
- IYHGenerator, Dermatological (Grenz Ray), Therapeutic X-Ray2Product Code
- IYICollimator, Orthovoltage, Therapeutic X-Ray2Product Code
- IYJCollimator, Low Voltage, Therapeutic X-Ray2Product Code
- IYKCollimator, High Voltage, Therapeutic X-Ray2Product Code
- IYLCollimator, Dermatological, Therapeutic X-Ray2Product Code
- JADSystem, Therapeutic, X-Ray2Product Code
- JAEMicrotron, Medical2Product Code
- JAICouch, Radiation Therapy, Powered2Product Code
- JAQSystem, Applicator, Radionuclide, Remote-Controlled2Product Code
- KPQSystem, Simulation, Radiation Therapy2Product Code
- KPZGenerator, High Voltage, X-Ray, Therapeutic2Product Code
- KQADevice, Beam Limiting, X-Ray, Therapeutic2Product Code
- KXKSource, Brachytherapy, Radionuclide2Product Code
- LHNSystem, Radiation Therapy, Charged-Particle, Medical2Product Code
- MUJSystem, Planning, Radiation Therapy Treatment2Product Code
- MWWAccessory - Film Dosimetry System2Product Code
- NMPNeedle, Isotope, Reprocessed2Product Code
- NZTDosimeter, Ionizing Radiation, Implanted2Product Code
- OINProstate Seeding Kit2Product Code
- ONLConformal Brachytherapy Source2Product Code
- OVBHydrogel Spacer2Product Code
- PCTProstate Immobilizer Rectal Balloon2Product Code
- RGCX-Ray Field Indicator Light (Laser)1Product Code
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
AccuCheck
- Page Type
- Cleared 510(K)
- 510(k) Number
- K250696
- 510(k) Type
- Traditional
- Applicant
- Manteia Technologies Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/24/2025
- Days to Decision
- 231 days
- Submission Type
- Summary