FDA.reportPublic FDA data

3D Accuitomo XYZ Slice View Tomograph

Primary DI
04548213016341
Brand
3D Accuitomo XYZ Slice View Tomograph
Company
J.MORITA MFG.CORP.
Model
MCT-1
Published
2020-03-21
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
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073695000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K0736950003D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17J. Morita USA, Inc.2008-04-09JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04548213016341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04548213016341045482130163414548213016341

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity8 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius43 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
693811465
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04548213056538Root ZX3RZX3 Type: RCM2023-06-27
04548213056545Root ZX3RZX3 Type: HF2023-06-27
04548213021260Spaceline EMCIACU-5802026-04-15
04548213015641Root ZX miniRCM-72026-04-07
04548213055999J. MORITA MFG. CORP.TR-ZX2 Type PLUS2023-03-06
04548213027408J. MORITA MFG. CORP.CA-5IF2023-02-01
04548213060153STERLINGBEN-4HEX-O-KV-452026-02-20
04548213060160STERLINGBEN-4HG-O-KV2026-02-20
04548213060177STERLINGBEN-4HG-O-NK2026-02-20
04548213057320TWINPOWER TURBINE 4HPAR-4HG-O2026-02-03
04548213057337TWINPOWER TURBINE 4HPAR-4HG-O-KV2026-02-03
04548213057344TWINPOWER TURBINE 4HPAR-4HG-O-NK2026-02-03
04548213057368TWINPOWER TURBINE 4HPAR-4HG-O-WH2026-02-03
04548213057375TWINPOWER TURBINE 4HPAR-4HG-O-SR2026-02-03
04548213745043Midwest 45 FBE NFO7450442023-08-18
04548213745241Midwest 45 K-Style NFO7452442023-08-18
04548213016556TORQTECHCA-5IF-O2022-12-19
00887919758013EndoSync A.I.RCM-75025412U02022-12-12
00887919832249EndoSync PLUSTR-CM5027135U02022-12-12
04548213008476N/ACP42022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10884521785977superDimensionCovidien LPJAK2026-05-29
10884521851184superDimensionCovidien LPJAK2026-05-29
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
B319LSN1LSNIMAGING BIOMETRICS, LLCJAK2026-04-14
B720BX360ELUNG230Brainomix 360 e-LungBRAINOMIX LIMITEDJAK2026-03-30
08719326703824LungQ®Thirona B.V.JAK2026-02-12
10841962119457Symphony Locating Bar, Prodigy2™QfixJAK2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
10884521852198superDimensionCovidien LPJAK2025-05-18
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
10810068810971Monarch Endoscopy ControllerAuris Health, Inc.JAK2025-03-05
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.JAK2025-03-03
10810068810582Monarch™ Tower Software v4.1.0Auris Health, Inc.JAK2025-03-03
10810068810599Monarch™ Cart Software v4.1.0Auris Health, Inc.JAK2025-03-03
M722CD25030CA241430ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-02-12
04987670105579Aquilion ONECANON INC.JAK2025-01-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17