FDA.reportPublic FDA data

3600

Primary DI
00854810007069
Brand
3600
Company
IcRco, Inc.
Model
M
Catalog number
500-0150-04
Device description
The iCR 3600M is a digital mammography computed radiography (CR) scanner manufactured by iCRco. It utilizes True Flat Scan Path technology to read phosphor plates without rollers, paired with ICE-M image processing algorithms designed specifically for mammography in addition to general radiography application
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
MUEFull Field Digital, System, X-Ray, Mammographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUEFull Field Digital, System, X-Ray, MammographicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854810007069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854810007069008548100070698548100070690854810007069

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
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
008548100072123600SF500-0150-022026-07-22
00854810007229iCRco Clarity Viewer5500-0197-492026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809394330807Bellalun 2DVIEWORKS CO., LTD.MUE2026-07-20
08052405210203SERENYS DRMETALTRONICA SPAMUE2026-05-25
08052405210050HELIANTHUSMETALTRONICA SPAMUE2026-03-24
00198953109281Senographe PristinaGE MEDICAL SYSTEMSMUE2025-12-01
10198953054311not applicableGE MEDICAL SYSTEMSMUE2025-11-28
08809244065088GenorayGENORAY CO., LTD.MUE2025-07-24
15420045517851Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517882Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517899Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517905Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517912Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517929Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517936Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517943Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517950Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517967Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517974Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517981Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517998Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
08809394330357VIVIX-M 1824SVIEWORKS CO., LTD.MUE2025-07-15
08809394330364VIVIX-M 2430SVIEWORKS CO., LTD.MUE2025-07-15
088000186022562430TCARayence Co., Ltd.MUE2025-04-08
00195278914026Senographe PristinaGE MEDICAL SYSTEMSMUE2025-01-09
10195278901764Not ApplicableGE MEDICAL SYSTEMSMUE2025-01-09
00195278866899not applicableGE MEDICAL SYSTEMSMUE2024-06-07
04056869987187MAMMOMAT B.brilliantSiemens Healthcare GmbHMUE2024-04-20
00195278719812not applicableGE MEDICAL SYSTEMSMUE2024-04-11
00195278795724not applicableGE MEDICAL SYSTEMSMUE2024-01-22
00195278711229not applicableGE MEDICAL SYSTEMSMUE2023-09-14
00195278655141not applicableGE MEDICAL SYSTEMSMUE2023-07-28