DoseGuard

GUDID 00860183001580

The ZAP-X includes an integrated transit dosimetry system, referred to as DoseGuard. This system provides an extra layer of patient safety by comparing measured and planned exit fluence and pausing the delivery if a deviation is detected.

ZAP SURGICAL SYSTEMS, INC.

Stereotactic radiosurgery/radiation therapy linear accelerator system

• Primary Device ID: 00860183001580
• NIH Device Record Key: cc438ad4-672f-49b4-a2a3-59d0b2bdf8d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DoseGuard
• Version Model Number: 300158
• Company DUNS: 082344400
• Company Name: ZAP SURGICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860183001580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250392

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-25
• Device Publish Date: 2025-11-17

Devices Manufactured by ZAP SURGICAL SYSTEMS, INC.

• 00860014658303 - PinZ Patient Immobilizer: 2025-11-25 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 Immobilizer: 2025-11-25 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 System: 2025-11-25 The dedicated software application used to create, optimize, and review treatment plans for the ZAP-X Radiosurgery System. It pr
• 00860183001580 - DoseGuard: 2025-11-25The ZAP-X includes an integrated transit dosimetry system, referred to as DoseGuard. This system provides an extra layer of patient safety by comparing measured and planned exit fluence and pausing the delivery if a deviation is detected.
• 00860183001580 - DoseGuard: 2025-11-25 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, Immobilizer: 2025-11-25 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 System: 2018-10-01 The Zap-X Radiosurgery System (“Zap-X System”) is a computer-controlled system for performing non-invasive stereotactic radi
• 00860183001511 - Zap-X Treatment Delivery Software: 2018-10-01 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 Software: 2018-10-01 The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a com