DICOMVIEW— 510(k) K954479

Substantially Equivalent

Heartlab, Inc.

FDA 510(k) clearance K954479 for DICOMVIEW, Substantially Equivalent on 1996-02-21. Applicant: Heartlab, Inc.. Device class: 1.

Clearance details

Applicant: Heartlab, Inc.
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1995-09-26
Decision date: 1996-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Providence, RI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LMD

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K992698 — STENTOR, PAGEVIEW1999-10-25
K992426 — RAYPAX WEB CLINICAL SYSTEM1999-10-13
K992352 — ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.01999-09-29
K991537 — SAMSUNG RAYPAX SYSTEM1999-07-06

More clearances from Heartlab, Inc.

K050858 — ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM2005-06-29
K050228 — AGFA HEARTLAB CARDIOVASCULAR2005-02-18
K042042 — ULTRASOUND CAPTURE SYSTEM2004-09-21
K040896 — MODIFICATION TO ENCOMPASS2004-07-16
K954860 — ECHONET1995-12-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.