FDA.reportPublic FDA data

ATMOS

Primary DI
04250365190717
Brand
ATMOS
Company
ATMOS MedizinTechnik GmbH & Co. KG
Model
iQam
Device description
The iQam is an endoscopic camera. It is intended to be connected to a flexible or rigid endoscope for digitization of the endoscopic image. The digital image can be viewed on a PC including video software that needs to be connected to the product.
Published
2024-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FWGCamera, Television, Endoscopic, With Audio

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWGCamera, Television, Endoscopic, With AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250365190717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250365190717042503651907174250365190717

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
319591939
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250365195071ATMOSC 051 Thorax2025-03-25
04250365142273ATMOSVariotherm plus2024-11-27
04250365142297ATMOSHygrotherm plus2024-11-27
04250365143065ATMOSVarioair2024-11-27
04250365149791ATMOSC 21 Economy - function column (230 V~)2024-11-27
04250365149807ATMOSC 21 Economy - function column (115 V~)2024-11-27
04250365149814ATMOSC 21 Economy - function column (127 V~)2024-11-27
04250365149821ATMOSC 31 Economy - function column (230 V~)2024-11-27
04250365149838ATMOSC 31 Economy - function column (115 V~)2024-11-27
04250365149845ATMOSC 31 Economy - function column (127 V~)2024-11-27
04250365155471ATMOSHL 21 LED2024-11-27
04250365155488ATMOSHL 21 LED (examination set)2024-11-27
04250365155495ATMOSHL 21 LED (OT set)2024-11-27
04250365155839ATMOSLS 21 LED2024-11-27
04250365155860ATMOSLS 21 LED set, white2024-11-27
04250365156034ATMOSStrobo 21 LED2024-11-27
04250365164084ATMOSS 61 Servant ENT workstation (230 V~)2024-11-27
04250365164107ATMOSS 61 Servant ENT workstation (115 V~)2024-11-27
04250365164114ATMOSS 61 Servant ENT workstation (127 V~)2024-11-27
04250365166187ATMOSS 61 Servant Vision2024-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
68051887046715THD Procto Software SystemTHD SPAFWG2025-02-20
68051887043295THD Procto Software SystemTHD SPAFWG2023-12-14
68051887043301THD Procto Software SystemTHD SPAFWG2023-12-14
68051887043318THD Procto Software SystemTHD SPAFWG2023-12-14
68051887043325THD Procto Software SystemTHD SPAFWG2023-12-14
18033737712341THD Procto Software SystemTHD SPAFWG2022-10-07
58051887042642THD Procto Software SystemTHD SPAFWG2022-10-07
08033737713037THD Procto Software SystemTHD SPAFWG2021-07-19
18033737712389THD Procto Software SystemTHD SPAFWG2021-07-19
00815440022228SenhanceAsensus Surgical, Inc.FWG2021-02-19
04961333242047N/APENTAX OF AMERICA, INC.FWG2018-03-08
04055207057469ENDOCAMRichard Wolf GmbHFWG2017-07-21
04961333231621n/aPENTAX OF AMERICA, INC.FWG2017-04-06
04055207055007NARichard Wolf GmbHFWG2016-09-23
04055207055014NARichard Wolf GmbHFWG2016-09-23