Cleared Traditional

K882959 - ENDOVAGINAL PROBE

K882959 is an FDA 510(k) clearance for ENDOVAGINAL PROBE, manufactured by Toshiba Medical Systems. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K882959 · Toshiba Medical Systems · Radiology device
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Aug 1988
Decision
35d
Days
Class 2
Risk

K882959 is an FDA 510(k) clearance for the ENDOVAGINAL PROBE, SMS-510VA. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on August 18, 1988 after a review of 35 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 Medical Systems devices

FDA 510(k) Submission Details - K882959

510(k) Number K882959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1988
Decision Date August 18, 1988
Days to Decision 35 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
72d faster than avg
Panel avg: 107d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

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 Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 429
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K882959.
MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K881834 · Ge Medical Systems Information Technologies · Aug 1988
GENESIS II TRANSCRANIAL PROBE
K883238 · Biosound, Inc. · Aug 1988
NIDEK US-3000
K882162 · Nidek, Inc. · Aug 1988
MODIFIED MODEL SSD-650 SYSTEM
K873452 · Ge Medical Systems Information Technologies · Jul 1988
EUB-450 DIAGNOSTIC ULTRASOUND DEVICE
K874211 · Hitachi Medical Corp. of America · Jun 1988
ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE
K875251 · Philips Medical Systems (Cleveland), Inc. · May 1988