CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)
Device Facts
| Record ID | K962364 |
|---|---|
| Device Name | CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) |
| Applicant | Codonics, Inc. |
| Product Code | LMC · Radiology |
| Decision Date | Nov 8, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2040 |
| Device Class | Class 2 |
Intended Use
The primary intended use of this device is to create hard copy prints or transparencies of medical images acquired from computer networks typically used in a medical environment.
Device Story
Codonics NP-1600M/NP-1600MD medical color printer; produces continuous-tone photographic quality hard copies/transparencies from electronic medical images; input via computer networks; used in medical environments; operated by technical/non-technical users; radiologists verify image quality against original CRT displays; no lossy compression; supports clinical documentation/review; enhances diagnostic workflow by providing physical records of digital images.
Clinical Evidence
Bench testing only. Image quality verified by radiologists comparing hard copy prints to original CRT images. Testing performed by technical users, non-technical users, and potential customers.
Technological Characteristics
Continuous tone medical color printer; hardware components certified to UL, CUL (CSA), TUV, CE, and FCC standards. No lossy compression used.
Indications for Use
Indicated for the production of continuous photographic quality hard copies of electronically created or stored medical images for use in medical environments.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Kodak XL7720 line of large format continuous tone printers
Related Devices
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- K083522 — SONY UP-DF750 DIGITAL FILM IMAGER · Sony Electronics, Inc. · Jan 9, 2009
- K042159 — KODAK COLOR MEDICAL IMAGER 1000 · Eastman Kodak Company · Sep 24, 2004
- K024188 — UP-DF500 FILMSTATION DIGITAL FILM IMAGER · Sony Medical Systems · Feb 4, 2003
- K971760 — COLORPOINT OR PROFESSIONAL COLORPOINT · Seiko Instruments USA, Inc. · Oct 1, 1997
