DRYSTAR 4500 PRINTER, MODEL 4500

• K Number: K010275
• Device Name: DRYSTAR 4500 PRINTER, MODEL 4500
• Manufacturer: AGFA MEDICAL IMAGING
• Date Cleared: 2001-04-27 ( 87 days)
• Product Code: LMC
• Regulation Number: 892.2040
• 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

§ 892.2040 Medical image hardcopy device.

(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.