Cleared Traditional

K040870 - SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS

K040870 is an FDA 510(k) clearance for SHIMADZU IMAGE AMPLIFIER, manufactured by Shimadzu Corp.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K040870 · Shimadzu Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
45d
Days
Class 2
Risk

K040870 is an FDA 510(k) clearance for the SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on May 17, 2004 after a review of 45 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 Corp. devices

FDA 510(k) Submission Details - K040870

510(k) Number K040870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2004
Decision Date May 17, 2004
Days to Decision 45 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 107d · This submission: 45d
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 188
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K040870.
CENTRION 500 C-ARM SYSTEM
K050866 · Osteosys Co.,Ltd · Apr 2005
FLXIS
K050692 · Philips Medical Systems North America Co. · Apr 2005
UNFORS PATIENT SKIN DOSIMETER (PSD)
K042698 · Unfors, Inc. · Oct 2004
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
K022899 · Philips Medical Systems North America Co. · Nov 2002
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
K022565 · Stereotaxis, Inc. · Oct 2002
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
K021021 · Siemens Medical Solutions USA, Inc. · Jun 2002