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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850059977637TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977644TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977651TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977668TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977675TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
75401622522125Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-08-07
00198953246405Xeleris V Processing and Review SystemG E MEDICAL SYSTEMS ISRAEL LTD.LLZ2026-08-03
00860011624349IntraOpVSPXironetic LLCLLZ2026-08-03
00862234000337Mosaic ViewerVirtual Radiologic CorporationLLZ2026-07-31
09358140000093Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-07-30
00866463000496STAGESpintech, Inc.LLZ2026-07-23
00854810007007AirDRIcRco, Inc.MQB2026-07-22
00854810007014AirDRIcRco, Inc.MQB2026-07-22
00854810007120iDRIcRco, Inc.MQB2026-07-22
00854810007205AirDRIcRco, Inc.MQB2026-07-22
00854810007229iCRco Clarity ViewerIcRco, Inc.LLZ2026-07-22
17540262200102Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-07-22
17540262090161Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-07-21
M722CP26183V261830ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-07-17
00854393006084VelocityVARIAN MEDICAL SYSTEMS, INC.LLZ2026-07-16
08809394330906VIVIX-S 4386WVIEWORKS CO., LTD.MQB2026-07-16
G874AVARAVIEWER0010Avara ViewerAVARA SOFTWARE LLCLLZ2026-07-13
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10