FDA.reportPublic FDA data

Nical Flat Panel

Primary DI
08056600520044
Brand
Nical Flat Panel
Company
NICAL SPA
Model
NFP Digital detector
Catalog number
NF3024C00
Published
2023-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053029000NDR+/DIVA-DNical Spa2006-01-06MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056600520044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056600520044080566005200448056600520044

GMDN Terms#

Term, Definition table
TermDefinition
Computed radiography digital imaging scannerA device/device assembly designed to be used with an analogue x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing; it is not dedicated to dental use. It consists of an image reader/scanner and may also include an exposure unit with imaging receptor (e.g., a cassette containing a plate), or additional supportive hardware (e.g., a printer). The image is acquired on a photostimulatable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435743877
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056600520051Nical Flat PanelNFP Digital detectorNFPMD43352023-10-09
08056600520006Nical Smart MicroNPR SystemNSM1001EU2023-09-28
08056600520013Nical Smart MicroNPR SystemNSM1001US2023-09-28
08056600520020Nical Smart MicroNPR SystemNSM1002EU2023-09-28
08056600520037Nical Smart MicroNPR SystemNSM1002US2023-09-28
08056600521331Nical Smart MicroNPR SystemNSM1001AA2023-09-28
08056600521348Nical Smart MicroNPR SystemNPR1000AA2023-09-28
08056600521355Nical Smart MicroNPR SystemNPR1000VE2023-09-28
08056600520303N23 CCD SystemN23N2360NANA2023-10-11
08056600520310N23 CCD SystemN23N2360NAN12023-10-11
08056600520327N23 CCD SystemN23N2360NARA2023-10-11
08056600520334N23 CCD SystemN23N2360NAR12023-10-11
08056600520341N23 CCD SystemN23N2360NINA2023-10-11
08056600520358N23 CCD SystemN23N2360NIN12023-10-11
08056600520365N23 CCD SystemN23N2360NIRA2023-10-11
08056600520372N23 CCD SystemN23N2360NIR12023-10-11
08056600520389N23 CCD SystemN23N2360NHNA2023-10-11
08056600520396N23 CCD SystemN23N2360NHN12023-10-11
08056600520402N23 CCD SystemN23N2360NHRA2023-10-11
08056600520419N23 CCD SystemN23N2360NHR12023-10-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03
00817886020493JointsMEDSTRAT, INC.LLZ2023-03-06
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05
00817886020455JointsMEDSTRAT, INC.LLZ2022-08-01