DIGITAL IMAGE ENHANCEMENT SYSTEM— 510(k) K900851

Name: FDA 510(k) clearance K900851
Creator: U.S. Food and Drug Administration
Published: 1990-05-11

Substantially Equivalent

Atomic Products Corp.

FDA 510(k) clearance K900851 for DIGITAL IMAGE ENHANCEMENT SYSTEM, Substantially Equivalent on 1990-05-11. Applicant: Atomic Products Corp.. Device class: 2.

Clearance details

Applicant: Atomic Products Corp.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1990-02-22
Decision date: 1990-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shirley, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Atomic Products Corp.

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K915541 — SPECT TABLE, MODEL #056-7601992-01-17
K913055 — THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-9001991-09-06
K904187 — ECONOMY C-ARM TABLE, MODEL # 056-0051990-11-29
K904623 — RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 2351990-11-06
K895799 — RECTILINEAR SCANNER MODEL #187-2701990-02-01

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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