Cleared Traditional

K950781 - COMPACT 7600

K950781 is an FDA 510(k) clearance for COMPACT 7600, manufactured by Ge Dec Medical Systems. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K950781 · Ge Dec Medical Systems · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
104d
Days
Class 2
Risk

K950781 is an FDA 510(k) clearance for the COMPACT 7600. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Ge Dec Medical Systems (Salt Lake City, US). The FDA issued a Cleared decision on June 5, 1995 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K950781

510(k) Number K950781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date June 05, 1995
Days to Decision 104 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
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 261
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K950781.
FLUORO CATHETER
K953950 · Cmt Medical Technologies, Ltd. · Sep 1995
FLUORECORD MODEL 762
K952493 · Syracuse Scientific, Inc. · Jun 1995
IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
K952456 · Fisher Imaging Corp. · Jun 1995
FLUOREX DTA-400A
K946081 · Toshiba America Medical Systems, In.C · May 1995
SIRESKOP SX
K951358 · Siemens Medical Solutions USA, Inc. · May 1995
SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES
K936236 · Shimadzu Medical Systems · May 1995
K950781 · COMPACT 7600
Download PDF FDA Summary Ge Dec Medical Systems