ACCULUPE

• K Number: K955184
• Device Name: ACCULUPE
• Manufacturer: E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC
• Date Cleared: 1996-01-24 ( 72 days)
• Product Code: LMB
• Regulation Number: 892.2010
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Regulation Number and Section

§ 892.2010 Medical image storage device.

(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.