MAXICAMERA 400 AC— 510(k) K841906

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K841906 for MAXICAMERA 400 AC, Substantially Equivalent on 1984-07-06. Applicant: General Electric Co.. Device class: 1.

Clearance details

Applicant: General Electric Co.
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 1984-05-08
Decision date: 1984-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYX

K230221 — QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)2023-08-28
K212587 — 3D-RD-S2023-02-22
K163687 — OLINDA EXM2017-07-19
K160933 — Discovery NM 750b Bopsy2016-11-18
K162052 — Sentinella 102, Sentinella 102 Horus2016-08-18

More clearances from General Electric Co.

K103489 — GE VEO RECONSTRUCTION OPTION2011-09-09
K082317 — GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION2008-09-26
K081921 — GE VIVID E9 ULTRASOUND2008-08-06
K073297 — GE LOGIQ P62007-12-18
K072952 — GE ECHOPAC2007-11-16

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