(202 days)
Not Found
No
The description focuses on phosphor plate technology, digitization, and standard postprocessing by a radiologist. There is no mention of AI or ML algorithms for image analysis, interpretation, or other functions.
No.
The device is described as an X-ray recording medium and system for diagnostic imaging, not for treating any medical condition.
Yes
The device is an X-ray recording medium that, as part of a system, processes radiographic images and sends them to a diagnostic workstation where a radiologist performs further postprocessing. This indicates its role in the diagnostic process.
No
The device description explicitly mentions hardware components such as an ID station, X-ray reader, diagnostic workstation, barcode reader, label printer, generator, overhead tube support, and integrated X-ray tube. While it includes software for postprocessing, it is not solely software.
Based on the provided text, the DIGISCAN 2 PLUS recording system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- DIGISCAN 2 PLUS Function: The DIGISCAN 2 PLUS is an X-ray recording system. It captures radiographic images using phosphor plate technology, which is a form of medical imaging. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for "all radiographic exposures for which conventional cassettes are used," which are imaging procedures.
- Device Description: The description focuses on the components and process of capturing and processing X-ray images.
Therefore, the DIGISCAN 2 PLUS falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
LLZ
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 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.
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.
Mentions image processing
System, Image Processing: CFR: 90 LLZ.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professional, radiologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(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).
0
SIEMENS
JUN 1 8 1996
955457
510(k) SUMMARY
GENERAL INFORMATION: I. Establishment: • Address:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ. 08830
- · Registration Number:
- ·Contact Person:
2240869
Kathleen Rutherford Manager, Regulatory Submissions Telephone Number: (908) 321- 4779 TELEFAX Number: (908) 321 - 4841
Date of Summary Preparation:
Device Name: · Trade Name:
·Common Name:
· Classification Name:
November 27, 1995
DIGISCAN 2 PLUS
Digital Luminescence Radiography System
System, Image Processing: CFR: 90 LLZ.
·Classification:
Performance Standards:
21 CFR, Subchapter J
Class II
SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE II. 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
1
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.
Ketlea Rutherford
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions
11/27/95
Date
Siemens Medical Systems, Inc.
Imaging Systems Group
186 Wood Avenue South Iselin, NJ 08830
Tel: (908) 321-4500 Fax: (908) 494-2250