PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
K964576 · Bennett X-Ray Corp. · IZH · Jan 10, 1997 · Radiology
Device Facts
| Record ID | K964576 |
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| Device Name | PROFILE MAMMOGRAPHY SYSTEM (M-PRO) |
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| Applicant | Bennett X-Ray Corp. |
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| Product Code | IZH · Radiology |
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| Decision Date | Jan 10, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 892.1710 |
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| Device Class | Class 2 |
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Intended Use
The Bennett Profile Mammography 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.
Device Story
Dedicated mammographic imaging system; x-ray source for mammography, biopsy, and spot examinations. Components: x-ray generator cabinet (Model M-1500G), tube stand with non-tilting C-arm, mammographic collimator (DM-1500), tube, operator control panel (Model M-1500C), and image receptor (film cassette holder or bucky). Microprocessor-controlled; single-phase 200-240 VAC power. C-arm is counterbalanced with electro-mechanical locks; fixed 76 cm source-to-image distance (SID). Used in clinical settings by radiology staff to produce mammographic images for diagnostic decision-making.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Microprocessor-controlled x-ray system. Components: M-1500G generator, DM-1500 collimator, M-1500C control panel. Fixed 76 cm SID. Electro-mechanical C-arm locks. Power: 200-240 VAC, 50/60 Hz.
Indications for Use
Indicated for patients requiring mammographic examinations, including biopsy and spot mammography.
Regulatory Classification
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.
Predicate Devices
- Bennett Contour Mammography System, Model M-CTR (K925725)
Reference Devices
- LORAD M-IV
- Instrumentarium Alpha RT
- GE Senographe 700T
- GE Senographe 800T
- Philips mammo DIAGNOST 3000
Related Devices
- K984092 — PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 · Trex Medical Corp. · Feb 5, 1999
- K984091 — CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 · Trex Medical Corp. · Feb 5, 1999
- K151645 — MAMMOMAT Fusion · Siemens Medical Solutions USA, Inc. · Sep 14, 2015
- K973856 — GIOTTO HT · Sitco, Inc. · Nov 21, 1997
- K012953 — GIOTTO IMAGE · Medx, Inc. · Nov 30, 2001
Submission Summary (Full Text)
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K964576
BENNETT Subsidiary of Trex Medical Corporation
JAN 10 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.
1. **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.
2. **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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445 Oak Street, Copiague, NY 11726-2719 USA • Tel: (516) 691-6100 • Fax: (516) 691-6103
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# BENNETT
*Subsidiary of*
## Trex Medical Corporation
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.
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445 Oak Street, Copiague, NY 11726-2719 USA • Tel: (516) 691-6100 • Fax: (516) 691-6103
