MX 125— 510(k) K812915

Clearance details

Applicant

General Electric Co.

Product code

Code ITY

Device class

Class 1

Regulation

21 CFR 892.1760

Advisory panel

Radiology

Date received

1981-10-19

Decision date

1981-11-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

• K000052 — X-RAY MONOBLOCK, MONOBLOCK XRS-60-3302000-02-10
• K933162 — MRX-7501993-10-07
• K923094 — MOLYBDENUM1993-03-04
• K923141 — PHILIPS PRE-FILTER OPTION1993-01-21
• K921129 — MRX-7001992-10-05

• 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

Other

1

Total

1

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 →