Cleared Traditional

M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ (K892355) - FDA 510(k) Clearance

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

K892355 · Hewlett-Packard Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1989
Decision
98d
Days
Class 2
Risk

K892355 is an FDA 510(k) clearance for the M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Germany, DE). The FDA issued a Cleared decision on July 24, 1989 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hewlett-Packard Co. devices

Submission Details

510(k) Number K892355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1989
Decision Date July 24, 1989
Days to Decision 98 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
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 191
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K892355.
ORION DIAGNOSTIC ULTRASOUND SYSTEM
K930768 · GE Medical Systems · Mar 1994
SIEMENS SONOLINE AC
K896480 · Siemens Medical Solutions USA, Inc. · Jul 1990
SIEMENS ENDO-P-PROBE
K894806 · Siemens Medical Solutions USA, Inc. · Oct 1989
ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.
K890772 · Boston Scientific Corp · May 1989
RT6800 ECHOCARDIOGRAPHY SYSTEM
K885228 · General Electric Co. · Mar 1989
HP 21362B TRANSESOPHAGEAL ULTRASOUND IMAGING TRANS
K884395 · Hewlett-Packard Co. · Jan 1989