FDA.reportPublic FDA data

3600

Primary DI
00854810007212
Brand
3600
Company
IcRco, Inc.
Model
SF
Catalog number
500-0150-02
Device description
A compact, single-plate small format computed radiography (CR) scanner designed for general radiography, orthopedics, and mobile imaging. Features a patented True Flat Scan Path to eliminate roller damage and preserve diagnostic image quality.
Published
2026-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LMADigitizer, Image, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMADigitizer, Image, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022810000COBRASCAN CR-1 FILMLESSRadiographic Digital Imaging, Inc.2002-10-11LMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854810007212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854810007212008548100072128548100072120854810007212

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 photostimulable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner.

Regulatory Flags#

DUNS number
610790276
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854810007007AirDRG3900-1596-012026-07-22
00854810007014AirDRLE500-1591-022026-07-22
00854810007045CHROMELF500-0274-022026-07-22
008548100070693600M500-0150-042026-07-22
008548100070763600LF500-0150-012026-07-22
00854810007113iDRL500-0177-122026-07-22
00854810007120iDR34500-0177-1242026-07-22
00854810007168CLARISCBCT500-0960-022026-07-22
00854810007199iXRSAirDR G3+INT-XRS-UNI-KIT2026-07-22
00854810007205AirDRG3+900-1596-012026-07-22
00854810007229iCRco Clarity Viewer5500-0197-492026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854810007045CHROMEIcRco, Inc.LMA2026-07-22
008548100070763600IcRco, Inc.LMA2026-07-22
00854810007113iDRIcRco, Inc.LMA2026-07-22
04056481140502Patient Data ManagerBrainlab SELMA2018-06-15
04056481138615PATIENT DATA MANAGER 2.4 INSTALLERBrainlab SELMA2018-02-09
04056481132453Origin Data Management / Patient Data ManagerBrainlab SELMA2017-01-02
00850677007082MDR Video TouchHYLAND LLCLMA2016-09-26
00851194002000Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002017Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002031Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002048Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002093Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002109Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002116Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002123Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002130Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002147Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00866389000167Radlink Laser Pro 16RADLINK, INC.LMA2016-09-21
00850677007068MDR Video CartHYLAND LLCLMA2016-09-19
00850677007075MDR Video SpeechHYLAND LLCLMA2016-09-19
00850677007020MDR VideoHYLAND LLCLMA2016-09-16
00850677007037Dicom BoxHYLAND LLCLMA2016-09-16
04056481006662Origin Data Management / Patient Data ManagerBrainlab SELMA2016-09-15