Cleared Traditional

K970063 - SERIES 7600 MOBILE DIGITAL C-ARM

K970063 is an FDA 510(k) clearance for SERIES 7600 MOBILE DIGITAL C-ARM, manufactured by Ge Dec Medical Systems. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K970063 · Ge Dec Medical Systems · Radiology device
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Mar 1997
Decision
63d
Days
Class 2
Risk

K970063 is an FDA 510(k) clearance for the SERIES 7600 MOBILE DIGITAL C-ARM. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Ge Dec Medical Systems (Salt Lake City, US). The FDA issued a Cleared decision on March 11, 1997 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Dec Medical Systems devices

FDA 510(k) Submission Details - K970063

510(k) Number K970063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1997
Decision Date March 11, 1997
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 256
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K970063.
TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C
K982427 · Trex Medical Corp. · Sep 1998
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
K974355 · Ge Dec Medical Systems · Feb 1998
SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS
K970734 · Siemens Medical Solutions USA, Inc. · Apr 1997
PHILIPS MULTIDIAGNOST 4
K961374 · Philips Medical Systems, Inc. · Aug 1996
CLINIX MP
K960920 · Philips Medical Systems (Cleveland), Inc. · May 1996
PHILIPS DCI-SX
K921219 · Philips Medical Systems, Inc. · Apr 1994