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
- PCSLiver Iron Concentration Imaging Companion Diagnostic For Deferasirox2Product Code
- PDKCream For X-Ray Attenuation2Product Code
- QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture2Product Code
- QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer2Product Code
- QJUImage Acquisition And/Or Optimization Guided By Artificial Intelligence2Product Code
- 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
- Submissions with No Product CodeMiscellaneous
- 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
Cream For X-Ray Attenuation
- Page Type
- Product Code
- Definition
- The x-ray attenuating cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a gloved hand, followed by donning a second glove. The X-ray attenuating cream is intended to be used during medical procedures where its necessary for hands to be exposed to radiation to offer some degree of protection from radiation exposure.
- Physical State
- X-ray attenuating cream
- Technical Method
- The device consists of a non-toxic, non-heavy metal, radiation absorbing material in a formulated base. Radiation is blocked by the device via absorption of the photon energy from ionizing radiation. This photon energy is dissipated as phonon energy within the atomic lattice structure of the radiation absorbing material.
- Target Area
- Healthcare Professional's hands
- Regulation Medical Specialty
- Radiology
- Review Panel
- Radiology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 892.6510
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code PDK is linked to regulation 21CFR892.6510, which does not seem to exist yet. It may be pending at the moment.