Cleared Traditional

C-ARM TABLE IVS-100 (K963888) - FDA 510(k) Clearance

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

K963888 · Shimadzu Medical Systems · Radiology device
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Dec 1996
Decision
83d
Days
Class 2
Risk

K963888 is an FDA 510(k) clearance for the C-ARM TABLE IVS-100. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Shimadzu Medical Systems (Torrance, US). The FDA issued a Cleared decision on December 18, 1996 after a review of 83 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 Shimadzu Medical Systems devices

Submission Details

510(k) Number K963888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1996
Decision Date December 18, 1996
Days to Decision 83 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 107d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 59
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K963888.
EXPEDIO 500D R&F X-RAY SYSTEM
K011624 · GE Medical Systems · Jun 2001
CAREGRAPH
K982319 · Siemens Medical Solutions USA, Inc. · Sep 1998
FLUOROSPOT COMPACT
K982028 · Siemens Medical Solutions USA, Inc. · Jul 1998
SIREGRAPH CF
K960266 · Siemens Medical Solutions USA, Inc. · Mar 1996
SIRESKOP SX
K951358 · Siemens Medical Solutions USA, Inc. · May 1995
NRF SYSTEM
K944973 · Philips Medical Systems (Cleveland), Inc. · Dec 1994