DIGISCAN 2 PLUS
K955457 · Siemens Medical Solutions USA, Inc. · LLZ · Jun 18, 1996 · Radiology
Device Facts
| Record ID | K955457 |
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| Device Name | DIGISCAN 2 PLUS |
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| Applicant | Siemens Medical Solutions USA, Inc. |
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| Product Code | LLZ · Radiology |
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| Decision Date | Jun 18, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 892.2050 |
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| Device Class | Class 2 |
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| Attributes | Pediatric |
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Intended Use
The DIGISCAN 2 PLUS recording system may be used for all radiographic exposures for which conventional cassettes are used, such as pediatrics, trauma, bone, neuro, GI, mobile radiography and vascular radiography.
Device Story
Digital Luminescence Radiography system using phosphor plate technology as X-ray recording medium; replaces conventional silver halide screens. System components: ID station (barcode reader, label printer), X-ray reader, and MagicView diagnostic workstation. Healthcare professionals enter patient/exposure data at ID station; X-ray reader digitizes radiographic information from storage phosphor plates; data transmitted to workstation for radiologist post-processing, hardcopy output, or archiving. Used in clinical settings for routine radiography. Wide dynamic range minimizes over/under exposures, potentially reducing patient radiation dose. DIGISCAN 2T PLUS model includes integrated generator, overhead tube support, and X-ray tube for thoracic imaging.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Phosphor plate technology; X-ray recording medium. System includes ID station, X-ray reader, and MagicView diagnostic workstation. Connectivity via digital data transfer to workstation/archive. Complies with 21 CFR Subchapter J performance standards.
Indications for Use
Indicated for patients requiring routine radiographic examinations, including pediatric, trauma, bone, neuro, GI, mobile, and vascular radiography.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
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).
Predicate Devices
- SIEMENS DIGISCAN 2 (K924459)
Reference Devices
- Fuji AC-3 (K944046/S1)
- Fuji 9000 (K944046/S1)
- Fuji 9501 (K944046/S1)
Related Devices
- K123005 — DDRVERSA MOTION · Swissray Medical AG · Dec 7, 2012
- K061538 — ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200 · Alara, Inc. · Jun 30, 2006
- K153142 — Carestream DRX-1 System with DRX Plus 4343 Detectors · Carestream Health, Inc. · Nov 25, 2015
- K121948 — CR 10-X DIGITIZER · Agfa Healthcare N.V. · Jul 20, 2012
- K211790 — DX-D Imaging Package with XD Detectors · Agfa N.V. · Jul 30, 2021
Submission Summary (Full Text)
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JUN 18 1996
K 955457
# SIEMENS
## 510(k) SUMMARY
### I. GENERAL INFORMATION:
#### Establishment:
- Address: Siemens Medical Systems, Inc.
186 Wood Avenue South
Iselin, NJ. 08830
- Registration Number: 2240869
- Contact Person: Kathleen Rutherford
Manager, Regulatory Submissions
Telephone Number: (908) 321-4779
TELEFAX Number: (908) 321-4841
#### Date of Summary Preparation:
November 27, 1995
#### Device Name:
- Trade Name: DIGISCAN 2 PLUS
- Common Name: Digital Luminescence Radiography System
- Classification Name: System, Image Processing: CFR: 90 LLZ.
- Classification: Class II
#### Performance Standards:
21 CFR, Subchapter J
### II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION.
#### Performance Standards:
All components to which the above referenced performance standards apply are certified to conform with 21 CFR Subchapter J.
#### Device Description:
The DIGISCAN 2 PLUS is an X-ray recording medium used for routine radiographic examinations. Instead of utilizing conventional radiographic screens (e.g. silver halide), the DIGISCAN 2 PLUS system employs phosphor plate technology. The system may be used for all radiographic exposures in which conventional cassettes are used, such as GI, and vascular radiography. The processed radiographic images may be sent to a hardcopy device, or an archive.
The DIGISCAN 2 PLUS will be made commercially available in three models: the DIGISCAN 2H PLUS, DIGISCAN 2C PLUS and the DIGISCAN 2T PLUS. The
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# SIEMENS
DIGISCAN 2H PLUS and 2C PLUS systems essentially differ only in throughput time, cassette use/reuse time and cassette formats. Unlike the 2H PLUS and 2C PLUS, the DIGISCAN 2T PLUS is a thoracic imaging system that operates on the basis of phosphor plate technology and is configured with a generator, an overhead tube support with synchronization control, and an integrated X-ray tube.
## Intended Use:
The DIGISCAN 2 PLUS recording system may be used for all radiographic exposures for which conventional cassettes are used, such as pediatrics, trauma, bone, neuro, GI, mobile radiography and vascular radiography.
## Technological Characteristics:
The DIGISCAN 2 PLUS basic systems are comprised of an ID station, an X-ray reader and a diagnostic workstation. The ID station is an interactive station through which the trained healthcare professional may enter patient data and other exposure data. Included in the ID station configuration is a barcode reader and label printer for easy cassette identification. The X-ray reader reads out the radiographic information retained within the storage phosphor plates. The signal is then digitized and sent to an interactive diagnostic workstation (MagicView) where further postprocessing may be performed by a radiologist.
## General Safety and Effectiveness Concerns:
Instruction for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and efficacious manner. The DIGISCAN 2 PLUS is a recording medium which does not come in direct contact with the patient, nor does it control the delivery of energy, the administration of parenteral drugs, or life sustaining functions. In addition, the wide dynamic range of the system minimizes the occurrence of over and under exposures, which concomitantly reduces the applied patient dosage.
## Substantial Equivalence:
The SIEMENS DIGISCAN 2 PLUS is substantially equivalent to the SIEMENS DIGISCAN 2 which was described in K924459, and received FDA clearance on 12/17/92. The DIGISCAN 2 PLUS has been designed with increased throughput capacity and data management abilities compared to the predicate device DIGISCAN 2.
The X-ray readers configured with the DIGISCAN 2 PLUS systems are the Fuji AC-3, Fuji 9000 and the Fuji 9501 manufactured by FUJI Photo Company, Ltd.. The X-ray readers are new high throughput readers which were the subject of premarket notification K944046/S1 and received FDA clearance on May 11, 1995.
Kathleen Rutherford
Manager, Regulatory Submissions
11/27/95
Siemens Medical Systems, Inc.
Imaging Systems Group
186 Wood Avenue South
Iselin, NJ 08830
Tel: (908) 321-4500
Fax: (908) 494-2250
