(59 days)
#002472, #000976
No
The document describes standard image processing and 3D reconstruction techniques, but there is no mention of AI or ML algorithms being used for image analysis, diagnosis, or any other function.
No.
The device is intended for diagnostic imaging and biopsy, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Delta 32 and Delta 32 TACT® are intended to be used for diagnostic digital spot and 3D imaging". The "Device Description" also refers to it as a "mammographic diagnostic digital mammography spot and 3D imaging system".
No
The device description explicitly states that the system includes hardware components such as a base mammographic system (Diamond), a CCD camera, and a needle guiding system (Cytoguide biopsy unit). While a PC workstation performs software functions like image processing and 3D reconstruction, it is part of a larger hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device is a mammographic diagnostic digital mammography spot and 3D imaging system. It acquires images of the breast within the body (in vivo) using X-rays. It also has a component for stereotactic breast biopsy, which involves guiding a needle to take a tissue sample, but the primary function described is imaging.
- Intended Use: The intended use is for "diagnostic digital spot and 3D imaging, and optionally for digital stereotactic breast biopsy." This is an imaging and biopsy guidance system, not a system for analyzing samples in a lab.
The device is a medical imaging system used for diagnosis based on images of the breast, not on the analysis of biological samples.
N/A
Intended Use / Indications for Use
Delta 32 and Delta 32 TACT® are intended to be used for diagnostic digital spot and 3D imaging, and optionally for digital stereotactic breast biopsy. Delta 32 and Delta 32 TACT® are intended to be used with the base mammographic system Diamond. However, a PC workstation of Delta 32 and Delta 32 TACT® can also be used as stand-alone for viewing images taken by Delta 32 and Delta 32 TACT®. The TACT® add-on provides means for digital 3D spot imaging using 2D projection images acquired with the system.
Product codes
IZH
Device Description
Delta 32 and Delta 32 TACT® is a mammographic diagnostic digital mammography spot and 3D imaging system, which can also be used for digital stereotactic breast biopsy. The base system is the Diamond mammographic system (#K955411), on which the Delta 32 and Delta 32 TACT® is installed.
The images are acquired by a CCD camera identical to our Delta 32 (#K002472). The needle guiding system is the same than previously, Cytoguide biopsy unit (#K885020). A PC workstation receives images and computes the necessary needle coordinates for Cytoguide unit. The PC also performs the optional TACT® 3D reconstruction identically to the Delta 32 TACT® system described in (#K002472). The PC workstation can also be used as stand-alone for viewing digital mammography spot and 3D images taken by Delta 32 and Delta 32 TACT®.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Breast
Indicated Patient Age Range
from 46 to 63 (for the symptomatic cases in the performance study)
Intended User / Care Setting
Not Found
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
60 symptomatic cases (female, age from 46 to 63) were used to evaluate clinical diagnostic image quality. The evaluation compared the three-dimensional mammography system and digital diagnostic spot mammography system to screen and diagnostic film system in terms of subjective image quality using the Likert scale from +4 to -4.
Summary of Performance Studies
Study type: Clinical study.
Sample size: 60 symptomatic cases (female, age from 46 to 63).
Key results:
- TACT® 3D slices vs. DFM images: Average = 0.82, Std. Error = 0.15, t-test p
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains a series of characters that appear to spell out a word. The characters are stylized and some are connected. The word appears to be "THITAYIIIY".
10 July 2002
510(K) SUMMARY
SEP 1 2 2002
MANUFACTURER:
Instrumentarium Corp. Imaging Division (Street Address: Nahkelantie 160) P.O.Box 20 FIN-04301 Tuusula, Finland
+358-10-394 6500 Phone: Fax: +358-10-394 6501
Contact person: Kaija Jokela
UNITED STATES SALES REPRESENTATIVE (U. S. DESIGNATED AGENT):
Instrumentarium Imaging Inc. 300 West Edgerton Avenue Milwaukee, Wisconsin 53207
Phone: 414-747-1030 414-481-8665 Fax:
PRODUCT, CLASSIFICATION NAME
Delta 32 with optional add-on TACT® (Diagnostic digital mammography spot and 3D imaging, optional to digital stereotactic breast biopsy, system)
System, x-ray, mammographic/ IZH
Regulation number: 892.1710
SUBSTANTIAL EQUIVALENCE:
We consider this product is similar in design, composition and function to the following devices introduced into commercial distribution after May 28, 1976:
Delta 32 and Delta 32 Tact® #002472 Diamond #000976
The technological characteristics of Delta 32 and Delta 32 TACT® are the same than in the previous application (#K002472). This application shows that Delta 32 and Delta 32 TACT® can also be used for diagnostic examinations like Diamond (#K000976).
Instrumentarium Imaging (Nahkelantie 160) P.O. Box 20 • FIN-04301 TUUSULA, Finland • Tel. +358 10 394 6500 • Fax +358 10 394 6501 info@fi.instrumentarium.com · www.instrumentarium.com/imaging Instrumentarium Corporation · FIN-00031 INSTRUMENTARIUM. Finland · Trade Reg. No.12.570 · VAT FI01092226
1
ə məqinq
DESCRIPTION:
Delta 32 and Delta 32 TACT® is a mammographic diagnostic digital mammography spot and 3D imaging system, which can also be used for digital stereotactic breast biopsy. The base system is the Diamond mammographic system (#K955411), on which the Delta 32 and Delta 32 TACT® is installed.
The images are acquired by a CCD camera identical to our Delta 32 (#K002472). The needle guiding system is the same than previously, Cytoguide biopsy unit (#K885020). A PC workstation receives images and computes the necessary needle coordinates for Cytoguide unit. The PC also performs the optional TACT® 3D reconstruction identically to the Delta 32 TACT® system described in (#K002472). The PC workstation can also be used as stand-alone for viewing digital mammography spot and 3D images taken by Delta 32 and Delta 32 TACT®.
INTENDED USE:
Delta 32 and Delta 32 TACT® are intended to be used for diagnostic digital spot and 3D imaging, and optionally for digital stereotactic breast biopsy. Delta 32 and Delta 32 TACT® are intended to be used with the base mammographic system Diamond. However, a PC workstation of Delta 32 and Delta 32 TACT® can also be used as stand-alone for viewing images taken by Delta 32 and Delta 32 TACT®. The TACT® add-on provides means for digital 3D spot imaging using 2D projection images acquired with the system.
PERFORMANCE DATA:
The evaluation of Delta 32 and Delta 32 TACT® for diagnostic use is based on the clinical study. The evaluation has been done by comparing the clinical diagnostic image quality of the three-dimensional mammography system and digital diagnostic spot mammography system to screen and diagnostic film system in terms of subjective image quality. The Likert scale was used from +4 to -4, where +4 means that digital image was absolute better than film image and -4 that film image was absolute better than digital image. Digital 3D mammography imaging (TACT®), digital spot mammogram (DSM), screen-film mammography imaging (SFM) and diagnostic film imaging (DFM) exams were performed on 60 symptomatic cases (female, age from 46 to 63).
Following table summaries the result of the tests:
| (N=180) | Average | Std.
Error | t-test |
|-----------------------------------|---------|---------------|----------|
| TACT® 3D slices vs. DFM
images | 0.82 | 0.15 | p