Cleared Traditional

K990490 - SSA-320A JUST VISION 200/ SSA-325A JUST...

K990490 is the FDA 510(k) clearance for SSA-320A JUST VISION 200/ SSA-325A JUST... by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K990490 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
14d
Days
Class 2
Risk

K990490 is an FDA 510(k) clearance for the SSA-320A JUST VISION 200/ SSA-325A JUST VISION. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on March 2, 1999 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 K990490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1999
Decision Date March 02, 1999
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Consultant

Tuv Product Service, Inc.
CAROLE STAMP

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 408
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K990490.
GE LOGIQ 500
K991611 · General Electric Co. · Jun 1999
SSA-370A/POWERVISION 6000
K991710 · Toshiba America Medical Systems, In.C · Jun 1999
ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM
K983879 · Aloka Co., Ltd. · Mar 1999
GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW
K990226 · Ge Medical Systems, Inc. · Feb 1999
BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING
K982840 · Boston Scientific Corp · Nov 1998
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K981528 · Siemens Medical Solutions USA, Inc. · Oct 1998