Kodak Ektascan Image Manager

Q: What is the product code of K891690?

The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.

FDA 510(k) K891690 · Eastman Kodak Company

Substantially Equivalent

510(k) numberK891690

Submission

Device name: Kodak Ektascan Image Manager
Applicant: Eastman Kodak Company
Rochester, NY, US
Received: March 22, 1989
Decision date: June 15, 1989
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: LMB – Device, Digital Image Storage, Radiological
Device class: Class I (low risk)
Regulation: 21 CFR 892.2010
Specialty: Radiology

Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.

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K972380	Kodak Digital Science (KDS) Medical Image and Information Library (Miil)LMB · Traditional	Eastman Kodak Company	09/11/1997SE
K971848	TDK Medical Grade Cd-RLMB · Traditional	Tdk Electronics Corporation of America	08/15/1997SE
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Questions and answers

When was Kodak Ektascan Image Manager cleared by the FDA?

Kodak Ektascan Image Manager (K891690) received a 510(k) decision of Substantially Equivalent on June 15, 1989, 85 days after the submission was received.

What is the product code of K891690?

The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.