Cleared Traditional

K812963 - IBIS II

K812963 is an FDA 510(k) clearance for IBIS II, manufactured by Cgr Medical Corp.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K812963 · Cgr Medical Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1981
Decision
33d
Days
Class 2
Risk

K812963 is an FDA 510(k) clearance for the IBIS II. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Cgr Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on November 24, 1981 after a review of 33 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 Cgr Medical Corp. devices

FDA 510(k) Submission Details - K812963

510(k) Number K812963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1981
Decision Date November 24, 1981
Days to Decision 33 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 107d · This submission: 33d
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 154
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K812963.
HYPERLUX 30 IMAGE SYSTEM
K827489 · Cgr Medical Corp. · Nov 1982
LATERAL ANGULATING FLUORO SUSPENSION
K820184 · General Electric Co. · Feb 1982
DIGITAL FLUROGRAPHIC IMAGING SYSTEM
K813217 · Diasonics, Inc. · Dec 1981
FLUORICON L300 IMAGE INTENSIFIER
K812775 · General Electric Co. · Nov 1981
LATERAL ANGULATING FLUORO SUSPENSION SYS
K812561 · General Electric Co. · Oct 1981
CARDIAC 1000 TM
K811094 · American Edwards Laboratories · Jul 1981