Cleared Traditional

K812238 - D.I.V.A.S. (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812238 · Cgr Medical Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1981
Decision
31d
Days
Class 2
Risk

K812238 is an FDA 510(k) clearance for the D.I.V.A.S.. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Cgr Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1981 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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

Submission Details

510(k) Number K812238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1981
Decision Date September 11, 1981
Days to Decision 31 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 107d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 196
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K812238.
IC-Flow™ Imaging System 2.0
K243645 · Diagnostic Green GmbH · Sep 2025
Affirm 800
K243077 · Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · Jun 2025
Modus IR
K231986 · Synaptive Medical, Inc. · Mar 2024
EXPLORER AIR® II (8001, 8002, 8003)
K234090 · Surgvision GmbH · Mar 2024
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
K231075 · Carl Zeiss Meditec, Inc. · Jun 2023
SPY Portable Handheld Imaging (SPY-PHI) System
K230727 · Novadaq Technologies Ulc (A Part of Stryker) · Jun 2023