Fluoro Automatic Brightness Sys

FDA 510(k) K812217 · Keystone X-Ray, Inc.

Substantially Equivalent

510(k) numberK812217

Submission

Device name
Fluoro Automatic Brightness Sys
Applicant
Keystone X-Ray, Inc.
Mchenry, IL, US
Received
August 5, 1981
Decision date
September 16, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JAA – System, X-Ray, Fluoroscopic, Image-Intensified
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

Other 510(k)s with product code JAA

510(k)DeviceApplicantDecision
K253103Nexus DRF Digital X-ray Imaging SystemJAA · Traditional Varex Imaging Corporation05/29/2026SE
K251650Insight Enhanced™ DRF (EN-1002-01)JAA · Traditional Imaging Engineering, LLC09/16/2025SE
K242488Soteria E-ViewJAA · Traditional Omega Medical Imaging, LLC01/06/2025SE
K242948Adora DRFi (04550010)JAA · Traditional Nrt X-Ray A/S12/23/2024SE
K233380TRIDENT Mobile Fluoroscopy SystemJAA · Traditional Dornier Medtech America06/26/2024SE
K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA · Special Philips Medical Systems Dmc GmbH01/11/2024SE
K232910CombiDiagnost R90JAA · Special Philips Medical Systems Dmc GmbH10/19/2023SE
K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA · Special Canon Medical Systems Corporation09/12/2023SE
K220871NautilusJAA · Special Dornier Medtech America, Inc.04/18/2022SE
K212890Nyquist.IQJAA · Traditional Omega Medical Imaging, LLC12/13/2021SE

More from Omega Medical Imaging, LLC

510(k)DeviceDecision
K931486Intrex VSK Interoral Dental X-Ray UnitEAP · Traditional 11/23/1993SE
K930925Intrex Interoral Dental X-Ray UnitEAP · Traditional 07/13/1993SE
K883354Variable KV Intrex VSK 60 - 90 KVPEAP · Traditional 12/21/1988SE

Questions and answers

When was Fluoro Automatic Brightness Sys cleared by the FDA?

Fluoro Automatic Brightness Sys (K812217) received a 510(k) decision of Substantially Equivalent on September 16, 1981, 42 days after the submission was received.

What is the product code of K812217?

The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.