(57 days)
No
The description focuses on the hardware components and basic microprocessor control of the x-ray source, with no mention of AI, ML, or advanced image processing beyond standard mammography.
No.
The device is described as a "dedicated mammographic imaging system used for mammographic examinations" and an "x-ray source in the performance of mammographic examinations," indicating its purpose is for diagnostic imaging rather than therapy.
No
The device is described as a "mammographic imaging system" and "x-ray source in the performance of mammographic examinations". While imaging can be a component of diagnosis, the device itself generates images rather than interpreting them to diagnose.
No
The device description explicitly lists multiple hardware components (x-ray generator cabinet, tube stand, collimator, control panel, image receptor) and describes it as an x-ray source, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is a "dedicated mammographic imaging system used for mammographic examinations." This involves imaging the body directly, not analyzing samples taken from the body.
- Device Description: The description details an x-ray system with components like an x-ray generator, tube stand, collimator, control panel, and image receptor. These are all components of an imaging system, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
In vitro diagnostics are tests performed on samples taken from the human body to detect diseases, conditions, or infections. This device is an imaging system used to visualize internal structures of the body.
N/A
Intended Use / Indications for Use
The Bennett Profile mammography system, like the Bennett Contour M-CTR, LORAD M-IV, Instrumentarium Alpha RT, GE Senographe 700T and 800T, and Philips mammo DIAGNOST 3000 mammographic imaging systems, is a dedicated mammographic imaging system used for mammographic examinations.
Product codes
Not Found
Device Description
The Bennett Profile Mammographic System, Model M-PRO, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations and can be adapted for biopsy and spot mammographic examinations. It consists of the following components; an x-ray generator cabinet, Model M-1500G; tube stand with non-tilting C-arm; mammographic collimator (DM-1500) and tube; an operator control panel, Model M-1500C; and image receptor (film cassette holder or bucky).
The Profile Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz for operation. The Profile system's C-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The C-arm has a fixed source-to-image distance (SID) of 76 cm.
Mentions image processing
Not Found
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety functions of the Profile Mammography System have been rigorously tested and analyzed for conformance to requirements. In each case, these functions have performed as required, ensuring that each identified hazardous condition would not occur under simulated conditions. The Profile Mammography System fulfills its design requirements by providing the operator with the ability to perform safe and effective mammographic examinations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bennett Contour Mammography System, Model M-CTR (#K925725)
Reference Device(s)
LORAD M-IV, Instrumentarium Alpha RT, GE Senographe 700T and 800T, and Philips mammo DIAGNOST 3000
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/1 description: The image shows the logo for Bennett, a subsidiary of Trex Medical Corporation. The word "BENNETT" is in large, bold, black letters. To the right of the second "T" in Bennett is the phrase "Subsidiary of" in a smaller font. Below the word "BENNETT" is the phrase "Trex Medical Corporation" in a smaller, but still prominent, font.
JAN 1 0 1997
SECTION 2
SUMMARY AND CERTIFICATION
510(k) SUMMARY
| Submitted by: | Bennett Subsidiary of Trex Medical Corporation |
|---|---|
| Address: | 445 Oak Street, Copiague, NY 11726 |
| Phone: | (516) 691-6100, (516) 691-6103 (fax) |
| Contact: | John A. Shovary |
| Device Name: | Bennett Profile Mammography System, Model M-PRO |
| Equivalent Device: | Bennett Contour Mammography System, Model M-CTR (#K925725), |
| LORAD M-IV, Instrumentarium Alpha RT, GE Senographe 700T and 800T, | |
| and Philips mammo DIAGNOST 3000 | |
| Date: | November 8, 1996 |
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 as promulgated in 59 FR 64287-01 for §807.92.
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- Description of the Device: The Bennett Profile Mammographic System, Model M-PRO, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations and can be adapted for biopsy and spot mammographic examinations. It consists of the following components; an x-ray generator cabinet, Model M-1500G; tube stand with non-tilting C-arm; mammographic collimator (DM-1500) and tube; an operator control panel, Model M-1500C; and image receptor (film cassette holder or bucky).
The Profile Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz for operation. The Profile system's C-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The C-arm has a fixed source-to-image distance (SID) of 76 cm.
- Description of the Device: The Bennett Profile Mammographic System, Model M-PRO, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations and can be adapted for biopsy and spot mammographic examinations. It consists of the following components; an x-ray generator cabinet, Model M-1500G; tube stand with non-tilting C-arm; mammographic collimator (DM-1500) and tube; an operator control panel, Model M-1500C; and image receptor (film cassette holder or bucky).
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- Same Intended Use: The Bennett Profile mammography system, like the Bennett Contour M-CTR, LORAD M-IV, Instrumentarium Alpha RT, GE Senographe 700T and 800T, and Philips mammo DIAGNOST 3000 mammographic imaging systems, is a dedicated mammographic imaging system used for mammographic examinations.
Image /page/0/Picture/11 description: The image shows a logo for the President's "E" Award for Excellence in Exporting. The logo features a flag with the letter "E" on it, superimposed over a globe. The text "WINNER OF THE PRESIDENT'S 'E' AWARD" is written around the top of the globe, and "EXCELLENCE IN EXPORTING" is written around the bottom.
- Same Intended Use: The Bennett Profile mammography system, like the Bennett Contour M-CTR, LORAD M-IV, Instrumentarium Alpha RT, GE Senographe 700T and 800T, and Philips mammo DIAGNOST 3000 mammographic imaging systems, is a dedicated mammographic imaging system used for mammographic examinations.
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1 -
1
ubsidiary of rporation
The Bennett Profile Mammography System is substantially equivalent to currently marketed devices in terms of basic features, operation, and functionality. The safety functions of the Profile Mammography System have been rigorously tested and analyzed for conformance to requirements. In each case, these functions have performed as required, ensuring that each identified hazardous condition would not occur under simulated conditions. The Profile Mammography System fulfills its design requirements by providing the operator with the ability to perform safe and effective mammographic examinations.
Image /page/1/Picture/2 description: The image shows a logo for the President's "E" Award for Excellence in Exporting. The logo features a flag with the letter "E" on it, superimposed over a world map. The text "WINNER OF THE PRESIDENT'S 'E' AWARD" is arched above the flag, and the text "EXCELLENCE IN EXPORTING" is below the flag.
445 Oak Street, Copiague, NY 11726-2719 USA • Tel: (516) 691-6100 • Fax: (516) 691-6103