Cleared Traditional

K897115 - ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)

K897115 is the FDA 510(k) clearance for ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM) by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code IZI) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K897115 · Toshiba America Medical Systems, In.C · Radiology device
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Mar 1990
Decision
77d
Days
Class 2
Risk

K897115 is an FDA 510(k) clearance for the ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM). Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on March 13, 1990 after a review of 77 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 Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K897115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date March 13, 1990
Days to Decision 77 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
30d faster than avg
Panel avg: 107d · This submission: 77d
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 99
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K897115.
CATHETERIZATION C-ARM SUPPORT MH-51C(F)
K903373 · Shimadzu Medical Systems · Nov 1990
HICOR
K903375 · Siemens Gammasonics, Inc. · Oct 1990
PHILIPS INTEGRIS C2000 SYSTEM
K902542 · Philips Medical Systems North America, Inc. · Aug 1990
LC, CARDIAC POSITIONER #B5078A
K890348 · General Electric Co. · Feb 1989
MULTISKOP
K890352 · Siemens Medical Solutions USA, Inc. · Feb 1989
ANGIOSTAR
K884912 · Siemens Medical Solutions USA, Inc. · Feb 1989