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
- K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Cleared 510(K)
- K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)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)
Show All 257 Submissions
- 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
PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K850207
- 510(k) Type
- Traditional
- Applicant
- SYNCOR INTL. CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/1/1985
- Days to Decision
- 42 days