OTOPLAN

Primary DI
07616962000212
Brand
OTOPLAN
Company
CAScination AG
Model
3.1.0
Catalog number
20072
Published
2025-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QQEImage Management Software For Planning Of Otologic And Neurotologic Procedures

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQEImage Management Software For Planning Of Otologic And Neurotologic ProceduresRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242120000OTOPLANCascination AG2025-04-11QQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07616962000212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07616962000212076169620002127616962000212

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
485258433
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640167220021CAS-One IR Consumable Set General2.0500022024-06-17
17640167220028CAS-One IR Consumable Set General2.0500022024-06-17
07616962000250CAS-One IR Software4.1200162024-06-07
07640167222131CAS-One IR2.02022-06-10
07640167222414OTOPLAN2.0200722022-07-11
07640167220724OTOPLAN1.3200722022-04-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640167222414OTOPLANCAScination AGQQE2022-07-11
07640167220724OTOPLANCAScination AGQQE2022-04-19