Cleared Traditional

K841263 - CARDIOSCAN - TM BEING APPLIED FOR

K841263 is an FDA 510(k) clearance for CARDIOSCAN - TM BEING APPLIED FOR, manufactured by Interspec, Inc.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K841263 · Interspec, Inc. · Cardiovascular device
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Oct 1984
Decision
207d
Days
Class 2
Risk

K841263 is an FDA 510(k) clearance for the CARDIOSCAN - TM BEING APPLIED FOR. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Interspec, Inc. (Conshohocken, US). The FDA issued a Cleared decision on October 19, 1984 after a review of 207 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - 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 Interspec, Inc. devices

FDA 510(k) Submission Details - K841263

510(k) Number K841263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1984
Decision Date October 19, 1984
Days to Decision 207 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
82d slower than avg
Panel avg: 125d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXK Device Classification - Class 2, Special Controls

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 - DXK Echocardiograph

All 46
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K841263.
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769 · Hewlett-Packard Co. · Oct 1985
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
K852543 · Kontron Instruments, Inc. · Sep 1985
DEL MAR AVIONICS 8300 SECTOR IMAGER SYS
K844896 · Del Mar Avionics · Jun 1985
MAVIS C
K813002 · Philips Medical Systems (Cleveland), Inc. · Mar 1982
SKI 5000
K812646 · Smithkline Diagnostics, Inc. · Nov 1981
DC-1 CARDIAC IMAGING MODULE
K811556 · Diasonics, Inc. · Jul 1981