Question 1

Who is the manufacturer of KODAK X-OMAT 3000 RA PROCESSOR?

Accepted Answer

Eastman Kodak Company filed the 510(k) submission for KODAK X-OMAT 3000 RA PROCESSOR (K951396).

Question 2

What is the FDA product code for KODAK X-OMAT 3000 RA PROCESSOR?

Accepted Answer

IXW. It is classified under 21 CFR 892.1900 as a Class 2 device in the Radiology panel.

Question 3

When was KODAK X-OMAT 3000 RA PROCESSOR cleared by the FDA?

Accepted Answer

May 15, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for KODAK X-OMAT 3000 RA PROCESSOR?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like KODAK X-OMAT 3000 RA PROCESSOR?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K951396
Device Name	KODAK X-OMAT 3000 RA PROCESSOR
Applicant	Eastman Kodak Company
Product Code	IXW · Radiology
Decision Date	May 15, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1900
Device Class	Class 2

KODAK X-OMAT 3000 RA PROCESSOR

Device Facts

Regulatory Classification

Identification

Special Controls