Cleared Traditional

K870916 - SSD-633 PHASED ARRAY SECTOR/LINEAR ULTR...

K870916 is an FDA 510(k) clearance for SSD-633 PHASED ARRAY SECTOR/LINEAR ULTR..., manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K870916 · Ge Medical Systems Information Technologies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1987
Decision
137d
Days
Class 2
Risk

K870916 is an FDA 510(k) clearance for the SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on July 21, 1987 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - the FDA cardiovascular device 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K870916

510(k) Number K870916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1987
Decision Date July 21, 1987
Days to Decision 137 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 125d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOP Transducer, Ultrasonic

All 36
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K870916.
AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER
K871416 · Acuson Computed Sonography · Sep 1987
ACUSON L538 TRANSDUCER
K871506 · Acuson Computed Sonography · Sep 1987
SSD-725 ULTRASOUND SECTOR SCANNER
K870607 · Ge Medical Systems Information Technologies · Aug 1987
3MHZ ANNULAR ARRAY
K864980 · Philips Ultrasound, Inc. · May 1987
ACUSON L558 TRANSDUCER
K861579 · Acuson Computed Sonography · Jul 1986
ACUSON S519 TRANSDUCER
K861596 · Acuson Computed Sonography · Jul 1986