Cleared Traditional

K802635 - OPHTHALMO ECHOGRAPH MODEL ZD255G

K802635 is the FDA 510(k) clearance for OPHTHALMO ECHOGRAPH MODEL ZD255G by Jedmed Instrument Co.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K802635 · Jedmed Instrument Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1981
Decision
183d
Days
Class 2
Risk

K802635 is an FDA 510(k) clearance for the OPHTHALMO ECHOGRAPH MODEL ZD255G. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Jedmed Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 183 days - an extended review 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: 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 Jedmed Instrument Co. devices

Submission Details

510(k) Number K802635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1980
Decision Date April 23, 1981
Days to Decision 183 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
76d slower than avg
Panel avg: 107d · This submission: 183d
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 424
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K802635.
ATL'S MARK 100/300 ULTRASOUND SYSTEMS
K811572 · Advanced Technology Laboratories, Inc. · Aug 1981
MS-50 ULTRASONIC IMAGER
K811252 · Kontron Instruments, Inc. · Aug 1981
5CM SMALL PARTS SCANNER
K810914 · Smithkline Diagnostics, Inc. · May 1981
MARK 500 SYSTEM
K810073 · Advanced Technology Laboratories, Inc. · Mar 1981
VARIAN V3500 PHASED ARRAY ULTRASONOGRAPH
K802434 · Varian Assoc., Inc. · Feb 1981
MARK III ULTRASONIC SCANNING SYSTEM
K802437 · Advanced Technology Laboratories, Inc. · Jan 1981