iDR

Primary DI
00854810007120
Brand
iDR
Company
IcRco, Inc.
Model
34
Catalog number
500-0177-124
Device description
The iCRco iDR-34 is a cassette-less, stationary digital radiography (DR) system capable of regional scanning and long-length skeletal imaging. It features an integrated 17” x 34” active area scanning detector panel utilizing internal phosphor plate technology. The system provides a single-exposure, stitch-free imaging workflow for full-torso and spinal applications, eliminating the need for stitching software. It incorporates a 16-bit grayscale resolution scan processor and operates via proprietary X-Ray Capture (XC) acquisition software
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
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082450000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082450000IDRIcrco, Inc.2009-06-30MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854810007120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854810007120008548100071208548100071200854810007120

GMDN Terms#

Term, Definition table
TermDefinition
Indirect flat panel x-ray detectorAn electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.

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
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

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