FDA.reportPublic FDA data

NewTom

Primary DI
08033837931379
Brand
NewTom
Company
CEFLA SOCIETA' COOPERATIVA
Model
NewTom 5G XL
Catalog number
P70720008
Device description
X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display.
Published
2019-04-01
Public version status
Update
Distribution status
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
K183448000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183448000NewTom 5G XLCefla S.C.2019-03-08JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033837931379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033837931379080338379313798033837931379

GMDN Terms#

Term, Definition table
TermDefinition
Limited-view-field CT systemAn assembly of diagnostic x-ray computed tomography (CT) devices having a gantry whose design limits its use to head and neck and/or extremity imaging applications. Included are single or multiple fixed annular arrays of x-ray tubes and opposing detectors or x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure71 KiloPascal106 KiloPascal

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (704)598-0020service@cefladental.com

Regulatory Flags#

DUNS number
429341410
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033837933021CEFLAVENUS PLUS966010702026-10-13
08033837933045CEFLAVENUS PLUS966010902026-10-13
08033837938583CEFLAVENUS PLUS966010402026-10-13
08033837938606CEFLAVENUS PLUS966010412026-10-13
08033837938644CEFLAVENUS PLUS966011002026-10-13
08033837938682CEFLAVENUS PLUS966011012026-10-13
08033837938699CEFLAVENUS PLUS966010422026-10-13
08033837938705CEFLAVENUS PLUS966010432026-10-13
08033837938712CEFLAVENUS PLUS966010302026-10-13
08033837938729CEFLAVENUS PLUS966011022026-10-13
08033837938736CEFLAVENUS PLUS966010322026-10-13
08033837938743CEFLAVENUS PLUS966010332026-10-13
08033837938835no brandNeowise7XPD2026-05-11
08033837935889Anthosi-MMs FLUO955206732026-04-16
08033837935896Anthosi-MMr L FLUO955206722026-04-16
08033837935902Stern Weberi-XS4 FLUO955206752026-04-16
08033837935919Stern Weberi-XR3 L FLUO955206742026-04-16
08033837935926Castelliniimplantor LED FLUO955206772026-04-16
08033837935933Castellinihandy power LED FLUO955206762026-04-16
08033837938316CEFLAAPEX LOCATOR760002012026-03-31

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