FDA.reportPublic FDA data

SeeFactor CT3

Primary DI
86000594161101
Brand
SeeFactor CT3
Company
Epica Medical Innovations LLC
Model
9801101000
Catalog number
86000594161101
Device description
SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head includingthe ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ),other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use indiagnostic support. The device displays two and three dimensional images for each examined anatomical region.The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Published
2021-03-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed
OASX-Ray, Tomography, Computed, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2
OASX-Ray, Tomography, Computed, DentalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190856000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190856000SeeFactorCT3Epica International, Inc.2019-09-20OAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
86000594161101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8600059416110186000594161101

GMDN Terms#

Term, Definition table
TermDefinition
Cone beam computed tomography system, head/neckA stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4259417365d.naimey@epicainternational.com

Regulatory Flags#

DUNS number
079142095
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005941605SeeFactorCT3SeeFactorCT38600059416052021-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.JAK2026-10-19
03760305400246DUAL SIDED NEEDLE GUIDEQUANTUM SURGICALJAK2026-10-19
03760305400277PATIENT REFERENCE 2.0QUANTUM SURGICALJAK2026-10-19
19356870000045CAC4DMEDICAL LIMITEDJAK2026-10-13
19356870000090LDA4DMEDICAL LIMITEDJAK2026-10-13
00860016243804C-beamPulmera, Inc.JAK2026-10-10
06975066322066MeyerHefei Meyer Optoelectronic Technology Inc.OAS2026-09-30
06975066322080MeyerHefei Meyer Optoelectronic Technology Inc.OAS2026-09-30
06975066322097MeyerHefei Meyer Optoelectronic Technology Inc.OAS2026-09-30
06975066322103MeyerHefei Meyer Optoelectronic Technology Inc.OAS2026-09-30
00884838120433SmartCTPhilips Medical Systems Nederland B.V.JAK2026-09-28
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-09-21
00860015781925Bunkerhill Contrast AVCBunkerhill Health Inc.JAK2026-09-16
00884838129559CT Areta RT/Rembra RT UpgradesPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-08-21
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00860015781901CAC (Gated) AlgorithmBunkerhill Health Inc.JAK2026-05-13
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00198953085950PhotonovaGE Medical Systems, L.L.C.JAK2026-05-11
00884838129528CT RembraPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00884838129535CT Rembra RTPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00884838129542CT Areta RTPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
06974566270167FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566270181FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566271133FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566271294FUSSENFussen Technology Co., Ltd.OAS2025-11-24