MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR— 510(k) K931882

Name: FDA 510(k) clearance K931882
Creator: U.S. Food and Drug Administration
Published: 1993-08-23

Substantially Equivalent

Alphatek Corp.

FDA 510(k) clearance K931882 for MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR, Substantially Equivalent on 1993-08-23. Applicant: Alphatek Corp.. Device class: 2.

Clearance details

Applicant: Alphatek Corp.
Product code: Code IXW
Device class: Class 2
Regulation: 21 CFR 892.1900
Advisory panel: Radiology
Date received: 1993-04-14
Decision date: 1993-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IXW

view all

K111167 — XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT2011-08-18
K093503 — INTRAX FILM PROCESSOR2010-01-06
K091628 — OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX2009-08-21
K024342 — RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP10002003-04-23
K023801 — FILM PROCESSOR, MODEL LIFE RAY PRO 10002003-02-12

More clearances from Alphatek Corp.

view all

K023613 — AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.0362003-01-23
K931883 — AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.0331993-08-23
K925569 — AX-700LE AUTOMATIC X-RAY FILM PROCESSOR1993-01-15
K924430 — AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.0271992-11-27

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