FDA.reportPublic FDA data

aycan store

Primary DI
04260476510014
Brand
aycan store
Company
aycan Digitalsysteme GmbH
Model
v3
Published
2017-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LMBDevice, Digital Image Storage, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMBDevice, Digital Image Storage, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260476510014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260476510014042604765100144260476510014

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315026208
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
04260476510052aycan store / aycan webfrom v4.02.0022025-02-12
04260476510021aycan workstationv32016-09-19
04260476510038aycan mobilev1 (US)2016-09-19
04260476510045aycan xray-printv22017-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850631008858Roentgen WorksBrit Systems, LLCLMB2026-05-26
00850631008827Roentgen WorksBrit Systems, LLCLMB2026-03-05
04907034602476UR-4MDTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2026-01-09
00850631008810Roentgen WorksBrit Systems, LLCLMB2026-01-01
00850631008803Roentgen WorksBrit Systems, LLCLMB2025-12-11
00850631008797Roentgen WorksBrit Systems, LLCLMB2025-11-20
00857534006868IMRISmatrix 5.0IMRIS Imaging, Inc.LMB2025-09-18
00850631008759Roentgen WorksBrit Systems, LLCLMB2025-08-14
00850631008742Roentgen WorksBrit Systems, LLCLMB2025-08-07
00850631008735Roentgen WorksBrit Systems, LLCLMB2025-07-31
04907034602155UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602162UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602230UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602247UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602254UR-NEXT4KSTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602261UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602278UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602285UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602308UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602315UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602322UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602339UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602346UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602353UR-NEXT4KSTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602377UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602384UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602391UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602407UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602445UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602452UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31