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Pre-Sure

FDA UDI

Class II (US FDA UDI)

by Lazarus 3D

Identity

Trade Name
Pre-Sure FDA UDI
Generic Name
Radiology information system application software FDA UDI
Device Name
The Pre-Sure patient modeling system is a method for the creation of patient models. Importantly, and unlike other 3D modeling systems, in the Pre-Sure process the design and production of patient models is performed by Lazarus 3D or its affiliates (with physician input), and not by the End User. The Pre-Sure software process is FDA cleared for the analysis of patient radiological data to create a digital patient design, referred to as a “Digital Twin”. Digital Twins can be used by End Users, when viewed in an appropriately cleared viewing program, for a variety of uses including training, education, and surgical planning. Patient specific Digital Twins may be further used as an input to a 3D printing-based production process performed by Lazarus 3D. This process creates physical patient models, referred to as Pre-Sure models. Each individual patient’s model can be created rapidly from the patient’s radiological data. The resulting physical models of patient anatomy are primarily composed of silicone materials that can be cut, can be sutured, and in some cases can even bleed, and of hard plastic materials that can be sawed, drilled, and can accept screws. End Users of the Preoperative Surgical Rehearsal (Pre-Sure) device receive digital and/or physical patient anatomical models from Lazarus 3D. Digital models may be viewed by End Users using any program cleared for their intended use. The physical models are intended for adjunctive use along with other diagnostic tools and expert clinical judgment for diagnosis, patient management, and/or treatment selection for genitourinary, cardiovascular, craniofacial, gastrointestinal, neurological, musculoskeletal, respiratory, and pediatric applications. FDA UDI
Model / Reference
1 FDA UDI
Description
The Pre-Sure patient modeling system is a method for the creation of patient models. Importantly, and unlike other 3D modeling systems, in the Pre-Sure process the design and production of patient models is performed by Lazarus 3D or its affiliates (with physician input), and not by the End User. The Pre-Sure software process is FDA cleared for the analysis of patient radiological data to create a digital patient design, referred to as a “Digital Twin”. Digital Twins can be used by End Users, when viewed in an appropriately cleared viewing program, for a variety of uses including training, education, and surgical planning. Patient specific Digital Twins may be further used as an input to a 3D printing-based production process performed by Lazarus 3D. This process creates physical patient models, referred to as Pre-Sure models. Each individual patient’s model can be created rapidly from the patient’s radiological data. The resulting physical models of patient anatomy are primarily composed of silicone materials that can be cut, can be sutured, and in some cases can even bleed, and of hard plastic materials that can be sawed, drilled, and can accept screws. End Users of the Preoperative Surgical Rehearsal (Pre-Sure) device receive digital and/or physical patient anatomical models from Lazarus 3D. Digital models may be viewed by End Users using any program cleared for their intended use. The physical models are intended for adjunctive use along with other diagnostic tools and expert clinical judgment for diagnosis, patient management, and/or treatment selection for genitourinary, cardiovascular, craniofacial, gastrointestinal, neurological, musculoskeletal, respiratory, and pediatric applications. FDA UDI

Identifiers

Primary DI / UDI-DI
G18920 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiology information system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiology information system application software

Pre-Sure by Lazarus 3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology information system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lazarus 3D

Sources (1)

  • FDA UDI 0793cc63-de67-46c6-a3e2-fee77659380b 33 fields · synced May 30, 2026