Search Results
Found 1 results
510(k) Data Aggregation
K Number
K162002Device Name
Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay
Manufacturer
Date Cleared
2016-11-01
(104 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
ZDi, Solutions, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ZDi Z-Tilt is intended for use by trained medical professionals for patient support and immobilization during external beam radiation therapy in clinics and hospitals. The Z-Tilt and accessories provide patient comfort and stability in various positions for radiation treatment. The Z-Tilt and is used in the treatment of cancer under the supervision and administration of licensed doctors and clinical staff.
Device Description
The Z-Tilt is a patient-positioning device designed specifically for applications within Proton Therapy. The Z-Tilt features a thin, low-stopping power backboard able to hold the heaviest of patients treated with proton therapy. The Z-Tilt offers a scoop feature that acts as a seat for patients to rest against. This seat allows an easily reproducible, fixed hip position. The scoop prevents the patient from sliding down the tilt, and also ensures thoracic alignment in the treatment area. The Z-Tilt is sixteen inches wide at its widest point, tapering into a ten-inch square to receive another ZDi device, the Z-Square. The Z-Square easily indexes to the Z-Tilt backboard to securely lock and index the custom foam patient molds to the device. The Z-Tilt is designed to be strong and sturdy, but with minimal amounts of material in critical areas of potential beam passage. The Z-Tilt backboard is attached to a slim, strong base. The base is narrow in the middle to allow beam passage, but wide enough to prevent wobble. The cranial end of the base is also a ten-inch square, holding hinged support legs to brace the backboard at various positions equaling four, eight, and twelve degrees; the most commonly needed patient tilt positions. The Z-Tilt base is designed with indexing holes to index to any standard index bar used on treatment tables. It is designed to remain within sixteen inches wide to prevent interference with table edges, table tracks, and CT bores. The Z-Tilt will have marks on each hole for accurate reproducibility of the Z-Square indexing system and for the leg supports for the incline. The patient will be in contact with their custom mold used on top of the Z-System.
The associated accessories include:
- Z-Square Indexing System for patient mold reproducibility
- Z-Bar Index Bar for Z-Square mounting
- Z-Box for custom formation of patient molds
- Z-Pulls for arms-down reproducible arm positioning
- Z-Foam for various foam patient supports under the custom patient molds
- Z-Scoop for thoracic positioning on the Z-Tilt and table
- Z-Roll for lateral positioning of the Z-Tilt
Ask a Question
Ask a specific question about this device
Page 1 of 1