FDA.reportPublic FDA data

X-Guide

Primary DI
00817421023361
Brand
X-Guide
Company
XNAV TECHNOLOGIES LLC
Model
P008542
Device description
X-Guide 3.7.0 Linux Software
Published
2024-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PLVDental Stereotaxic Instrument
QRYDental Navigation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLVDental Stereotaxic InstrumentDental2
QRYDental Navigation SystemDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150222000
K192579000
K211701000
K232148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150222000X-Guide Surgical Navigation SystemX-Nav Technologies, LLC2015-10-08PLV
K192579000X-Guide Surgical Navigation SystemX-Nav Technologies, LLC2020-02-03PLV
K211701000X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC2022-02-01QRY
K232148000X-Guide Surgical Navigation SystemX-Nav Technologies, LLC2024-02-21QRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817421023361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817421023361008174210233618174210233610817421023361

GMDN Terms#

Term, Definition table
TermDefinition
Surgical planning/navigation-enhancement systemA mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
026096247
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817421021411X-GuideP010307P0103072021-01-25
00817421021336X-GuideP010303P0103032021-01-25
00817421021350X-GuideP010304P0103042021-01-25
00817421021374X-GuideP010305P0103052021-01-25
00817421021398X-GuideP010306P0103062021-01-25
00817421021435X-GuideP010308P0103082021-01-25
00817421021190X-GuideP0108572021-01-25
00817421021206X-GuideP0108602021-01-25
00817421021213X-GuideP0108692021-01-25
00817421021220X-GuideP0108702021-01-25
00817421021251X-GuideP0108732021-01-25
00817421021268X-GuideP0108742021-01-25
00817421022883FastMapP0120032025-01-31
00817421022920X-GuideP0085422024-12-09
00817421022852X-Guide FastMapP0119422024-06-24
00817421022791X-GuideP0118032024-10-08
00817421022784X-GuideP0085422024-09-06
00817421022814X-GuideP0085422024-09-06
00817421022821X-GuideP0085422024-09-06
00817421022753X-GuideP0085422024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810004900851O Rings for Yomi S TEE Screw Bag of 25NEOCIS INCPLV2026-06-03
00810004900639Yomi S Extra Oral Fiducial Array LLURNEOCIS INCPLV2025-12-01
00810004900646Yomi S Extra Oral Fiducial Array LRULNEOCIS INCPLV2025-12-01
00810004900653Yomi S Intra Oral Fiducial Array SmallNEOCIS INCPLV2025-12-01
00810004900660Yomi S Intra Oral Fiducial Array MediumNEOCIS INCPLV2025-12-01
00810004900677Yomi S Intra Oral Fiducial Array LargeNEOCIS INCPLV2025-12-01
00810004900684Yomi S YomiLink Teeth Posterior LLURNEOCIS INCPLV2025-12-01
00810004900691Yomi S YomiLink Teeth Posterior LRULNEOCIS INCPLV2025-12-01
00810004900707Yomi S YomiLink Arch LLURNEOCIS INCPLV2025-12-01
00810004900714Yomi S YomiLink Arch LRULNEOCIS INCPLV2025-12-01
00810004900721Yomi S YomiLink Teeth Anterior LLURNEOCIS INCPLV2025-12-01
00810004900738Yomi S YomiLink Teeth Anterior LRULNEOCIS INCPLV2025-12-01
00810004900745Yomi S YomiLink Bone Lower LLNEOCIS INCPLV2025-12-01
00810004900752Yomi S YomiLink Bone Lower LRNEOCIS INCPLV2025-12-01
00810004900769Yomi S YomiLink Bone Upper ULNEOCIS INCPLV2025-12-01
00810004900776Yomi S YomiLink Bone (U) Assembly (UR)NEOCIS INCPLV2025-12-01
00810004900783Yomi S Tracker End Effector AssemblyNEOCIS INCPLV2025-12-01
00810004900783Yomi S Tracker End Effector AssemblyNEOCIS INCQRY2025-12-01
00810004900790Yomi S YomiLink-TEE ScrewNEOCIS INCQRY2025-12-01
00810004900790Yomi S YomiLink-TEE ScrewNEOCIS INCPLV2025-12-01
00810004900806Yomi S TEE Flange ScrewNEOCIS INCQRY2025-12-01
00810004900806Yomi S TEE Flange ScrewNEOCIS INCPLV2025-12-01
00810004900813Yomi S Fiducial Array ScrewNEOCIS INCPLV2025-12-01
00810004900813Yomi S Fiducial Array ScrewNEOCIS INCQRY2025-12-01
00810004900820Yomi S Draping KitNEOCIS INCPLV2025-12-01
00810004900837Yomi S Robotic SystemNEOCIS INCPLV2025-12-01
00810004900837Yomi S Robotic SystemNEOCIS INCQRY2025-12-01
00810004900844Yomi S Starter KitNEOCIS INCPLV2025-12-01
00810004900622Neocis Guidance SystemNEOCIS INCQRY2025-05-02
00817421022920X-GuideXNAV TECHNOLOGIES LLCQRY2024-12-09