FDA.reportPublic FDA data

ImagingRing

Primary DI
19120075320013
Brand
ImagingRing
Company
medPhoton GmbH
Model
1.1
Published
2018-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161400000ImagingRing SystemMedphoton GmbH2016-12-08IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19120075320013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1912007532001319120075320013

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
300376801
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19120075320020ImagingRing r12026-04-21
19120075320105Mobile Monitor Cart System MMCS1A00932025-06-10
19120075320136Remote Control Charging Cart RCCS1A010522025-06-10
19120075320112ImagingRing m2P04-12025-05-28
19120075320129Loop-X2P04-22025-05-28
19120075320037ImagingRing1.22018-10-25
19120075320068ImagingRing m12021-03-22
19120075320075Loop-X1P04-22021-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850065937250eMotusEMPNIA INC.IYE2026-09-21
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00850065937304eMotusEMPNIA INC.IYE2026-09-21