FDA.reportPublic FDA data

Analogic ImpaCT

Primary DI
00814277020155
Brand
Analogic ImpaCT
Company
ANALOGIC CORPORATION
Model
10-79182-01
Device description
Analogic ImpaCT 16-slice
Published
2019-02-15
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
K182147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182147000CTXX85Analogic Corporation2018-09-07JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814277020155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814277020155008142770201558142770201550814277020155

GMDN Terms#

Term, Definition table
TermDefinition
Full-body CT systemAn assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with 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 special 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
019677418
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
90814277020035Pathfinder Shadow BK-T10-77322S-012016-09-17
90814277020042Pathfinder Shadow 10-77247S-012016-09-17
90814277020059Pathfinder Shadow (Aloka)10-77246S-012016-09-17
90814277020066Pathfinder Small Multi-Tool Instrument Clamp10-77260S-012016-09-17
90814277020073Pathfinder Large Multi-Tool Instrument Clamp10-77249S-012016-09-17
90814277020080Pathfinder Beacon10-77248S-012016-09-17
90814277020097Pathfinder Tracer10-77243S-012016-09-17
90814277020103Pathfinder Long Probe10-77242S-012016-09-17
90814277020110Pathfinder Tracked Probe10-77241S-012016-09-17
08294360350536Ultrasonix Medical Corporation00.035.0532017-11-17
08294360246341Ultrasonix Medical Corporation00.024.6342017-11-17
08294360350352Ultrasonix Medical Corporation00.035.0352017-11-17
08294360350499Ultrasonix Medical Corporation00.035.0492017-11-17
08294360350567Ultrasonix Medical Corporation00.035.0562017-11-17
08294360350581Ultrasonix Medical Corporation00.035.0582017-11-17
08294360350604Ultrasonix Medical Corporation00.035.0602017-11-17
08294360350611Ultrasonix Medical Corporation00.035.0612017-11-17
08294360350635Ultrasonix Medical Corporation00.035.0632017-11-17
08294360350642Ultrasonix Medical Corporation00.035.0642017-11-17
08294360350666Ultrasonix Medical Corporation00.035.0662017-11-17

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Primary DI, Brand, Company table
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10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
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B319LSN1LSNIMAGING BIOMETRICS, LLCJAK2026-04-14
B720BX360ELUNG230Brainomix 360 e-LungBRAINOMIX LIMITEDJAK2026-03-30
08719326703824LungQ®Thirona B.V.JAK2026-02-12
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10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
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M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
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10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
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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
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