Kit, Container, Head Immobilizer

GUDID 00860183001542

An optional accessory designed for rigid head immobilization. The device consists of a frame that is attached to the patient table and fixation pins that are affixed to the patient's head to minimize voluntary and involuntary patient movement and maintain the target position throughout the treatment session.

ZAP SURGICAL SYSTEMS, INC.

Stereotactic radiosurgery/radiation therapy linear accelerator system
Primary Device ID00860183001542
NIH Device Record Keyb1e7d61c-81b2-41df-b756-ff3bfe18eec0
Commercial Distribution StatusIn Commercial Distribution
Brand NameKit, Container, Head Immobilizer
Version Model Number300154
Company DUNS082344400
Company NameZAP SURGICAL SYSTEMS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860183001542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00860183001542]

Moist Heat or Steam Sterilization

[00860183001542]

Moist Heat or Steam Sterilization

[00860183001542]

Moist Heat or Steam Sterilization

[00860183001542]

Moist Heat or Steam Sterilization

[00860183001542]

Moist Heat or Steam Sterilization

[00860183001542]

Moist Heat or Steam Sterilization

[00860183001542]

Moist Heat or Steam Sterilization

[00860183001542]

Moist Heat or Steam Sterilization

[00860183001542]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-25
Device Publish Date2025-11-17

Devices Manufactured by ZAP SURGICAL SYSTEMS, INC.

00860014658303 - PinZ Patient Immobilizer2025-11-25 An optional accessory designed for rigid head immobilization. The device consists of a frame that is attached to the patient tab
00860183001542 - Kit, Container, Head Immobilizer2025-11-25An optional accessory designed for rigid head immobilization. The device consists of a frame that is attached to the patient table and fixation pins that are affixed to the patient's head to minimize voluntary and involuntary patient movement and maintain the target position throughout the treatment session.
00860183001542 - Kit, Container, Head Immobilizer2025-11-25 An optional accessory designed for rigid head immobilization. The device consists of a frame that is attached to the patient tab
00860183001573 - ZAP-Axon Treatment Planning System2025-11-25 The dedicated software application used to create, optimize, and review treatment plans for the ZAP-X Radiosurgery System. It pr
00860183001580 - DoseGuard2025-11-25 The ZAP-X includes an integrated transit dosimetry system, referred to as DoseGuard. This system provides an extra layer of pati
00860183001597 - Kit, Container, Fixation Pins, Immobilizer2025-11-25 An optional accessory designed for rigid head immobilization. The device consists of a frame that is attached to the patient tab
00860183001504 - Zap-X Radiosurgery System2018-10-01 The Zap-X Radiosurgery System (“Zap-X System”) is a computer-controlled system for performing non-invasive stereotactic radi
00860183001511 - Zap-X Treatment Delivery Software2018-10-01 The Zap-X Treatment Delivery Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a com
00860183001528 - Zap-X Treatment Planning Software2018-10-01 The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a com
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