Light Source System, Diagnostic Endoscopic

Product Code: OAY

General Optical Products / Medical

Definition: A Fluorescence System Intended For Use As An Adjunct To White Light Cystoscopy When Used In Combination With A Photosensitizer For The Detection Of Bladder Cancer. Patients With Known Or Suspected Bladder Cancer And/or Recurrence Of Bladder Cancer, In Patients Undergoing Diagnostic Testing For Bladder Cancer By Cystoscopy Or Positive Urine Cytology

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as OAY

2219Light Source System, Diagnostic Endoscopic

Total Product Life Cycle (TPLC) Devices

2219Light Source System, Diagnostic Endoscopic

Pre-market Approvals for OAY

P050027KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEMKARL STORZ ENDOSCOPY-AMERICA, INC.

Global Unique Device Identification Database

04048551402535Light Source System, Diagnostic Endoscopic
04048551402528Light Source System, Diagnostic Endoscopic
04048551350652Light Source System, Diagnostic Endoscopic
04048551289532Light Source System, Diagnostic Endoscopic
04048551073209Light Source System, Diagnostic Endoscopic
04048551073131Light Source System, Diagnostic Endoscopic
04048551073094Light Source System, Diagnostic Endoscopic
04048551064160Light Source System, Diagnostic Endoscopic
04048551064092Light Source System, Diagnostic Endoscopic
04048551063910Light source system, diagnostic endoscopic
04048551004654Light Source System, Diagnostic Endoscopic
04048551423547Light source system, diagnostic endoscopic
04048551423516Light source system, diagnostic endoscopic
04048551064085Light Source System, Diagnostic Endoscopic

Maude Adverse Events

HALOGEN LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2019-09-29
STORZ ICG LIGHT SOURCEKARL STORZ IMAGING, INC.2018-08-28
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