FDA.report

510(k) K912341

Device
MULTICAM I 8X10
Applicant
CAMTRONICS, LTD.
510(k) number
K912341
Product code
JAA  
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-26
Date received
1991-05-24
Regulation
892.1650
Classification name
System, X-ray, Fluoroscopic, Image-intensified
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
SCOTT J PEASE
Address
900 Walnut Ridge Dr. P.O. Box 950 Hartland WI US 53029 53029

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Other 510(k) Records For Product Code JAA  

510(k)DeviceApplicantDecision date
K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC2025-09-16
K242488Soteria E-ViewOmega Medical Imaging, LLC2025-01-06
K242948Adora DRFi (04550010)Nrt X-Ray A/S2024-12-23
K233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech America2024-06-26
K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH2024-01-11
K232910CombiDiagnost R90Philips Medical Systems Dmc GmbH2023-10-19
K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation2023-09-12
K220871NautilusDornier Medtech America, Inc.2022-04-18
K212890Nyquist.IQOmega Medical Imaging, LLC2021-12-13
K212837ProxiDiagnost N90Philips Medical Systems Dmc GmbH2021-09-21
K212145DR 800 with DSA, DR 800Agfa N.V.2021-08-31
K210469Insight Agile DRFImaging Engineering, LLC2021-07-27
K203428Ziehm Vision RFDZiehm Imaging GmbH2021-03-17
K203010Platinum dRF Imaging SystemApelem-Dms Group2021-01-22
K200965XR-MX/1000Karl Storz Endoscopy America, Inc.2020-12-29

Legacy Summary

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FDA Review

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