(381 days)
The RMF-2000 generates 2D digital mammography images. The RMF-2000 is intended to be used for screening and diagnosis of breast cancer. This unit is intended for use in the same clinical applications as traditional screen film mammography systems.
The system consists of a gantry with integrated high-voltage generator as well as an optional radiation shield with a height-adjustable control desk with an integrated Acquisition Workstation (AWS). The moveable swivel C-arm on the gantry contains the X-ray tube on the top end and the breast support with the X-ray detector on the bottom end. The detector is a full field digital mammography detector. RMF-2000 acquires digital mammographic images for diagnosis of the breast cancer. RMF-2000 is designed to be used in the same clinical application for 2D screening mammographic systems. The screening examination exposes X-rays to the left and the right breasts of the patient to acquire images. Also, the RMF-2000 can be used to additional precision diagnosis for breasts. The device's software provides an integrated solution for X-ray projection. It integrates with the X-ray generator and the digital detector and acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system, and print images through the DICOM printer.
The provided document is a 510(k) summary for the DRTECH Corporation's RMF-2000 Full-Field Digital Mammography system. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI/software as a medical device (SaMD).
However, I can extract information related to the device's performance evaluation as presented in the document, framed within the context of substantial equivalence. The document describes a clinical image evaluation to demonstrate that the images produced by the RMF-2000 are of sufficient quality for mammographic use and substantially equivalent to those from the predicate device.
Here's an attempt to answer your questions based on the provided text, acknowledging that the depth of information about "acceptance criteria" and the "study" is limited to what's required for a 510(k) submission showing substantial equivalence of an imaging device, not necessarily an AI/SaMD.
Acceptance Criteria and Device Performance
The document doesn't explicitly list "acceptance criteria" in a quantitative table for device performance in the way one might expect for a robust AI/SaMD study (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, the acceptance criterion for the clinical evaluation was implicitly the "sufficiently acceptable quality for mammographic usage" and "substantial equivalence to those from predicate device" concerning image quality, as determined by qualified physicians.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Image Quality | Images must be of sufficiently acceptable quality for mammographic usage. | "the images... were of sufficiently acceptable quality for mammographic usage" |
| Image Equivalence | Images must be substantially equivalent to those from the predicate device. | "the images are substantially equivalent to those from predicate device." |
| Safety & Effectiveness | Device introduces no new safety or efficacy issues compared to the predicate device and is adequate for its intended use. | "The RMF-2000 introduces no new safety or efficacy issues other than those already identified with the predicate device.""the device is adequate for its intended use." |
Study Details:
-
Sample size used for the test set and the data provenance:
- The document states "A clinical image evaluation... was conducted," but it does not specify the sample size (number of images or patients) used for this evaluation.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical image evaluation." It's retrospective as it involves evaluation of images.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "images, reviewed by MQSA qualified interpreting physicians."
- Number of experts: Not specified (e.g., it doesn't say how many physicians reviewed the images).
- Qualifications: "MQSA qualified interpreting physicians." MQSA (Mammography Quality Standards Act) qualification implies specific training and experience requirements for reading mammograms in the U.S.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not specify an adjudication method for the clinical image evaluation. It simply states "reviewed by MQSA qualified interpreting physicians."
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study comparing human readers with AI assistance versus without AI assistance was not done. The RMF-2000 is described as a digital mammography system (hardware + associated software for image acquisition and processing), not an AI algorithm for interpretation. The "clinical image evaluation" was to assess the image quality produced by the device, not to evaluate an AI's impact on human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of this document. This document describes a full-field digital mammography system, a medical device that produces images, not a standalone AI algorithm for image analysis. The evaluation was of the images produced by the device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is the expert assessment of image quality by MQSA qualified interpreting physicians and their determination of equivalence to images from a predicate device. There's no mention of pathology or outcomes data being used to establish a ground truth for disease presence, as the study's purpose was to evaluate device-produced image quality, not disease detection performance of an AI.
-
The sample size for the training set:
- This question is not applicable to the information provided. The document describes a full-field digital mammography system, not an AI model that requires a training set. The "clinical image evaluation" is a validation of the device's image output, not a dataset for training.
-
How the ground truth for the training set was established:
- This question is not applicable as there is no mention of a training set or AI model in the context of this 510(k) submission for the RMF-2000.
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January 26, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
DRTECH Corporation % Suyeon Back Assistant manager Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29 Dunchon-daero 541 beon-gil. Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216 KOREA
Re: K220073
Trade/Device Name: RMF-2000 Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: Class II Product Code: MUE Dated: December 14, 2022 Received: December 14, 2022
Dear Suyeon Back:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K220073 Device Name RMF-2000
Indications for Use (Describe)
The RMF-2000 generates 2D digital mammography images. The RMF-2000 is intended to be used for screening and diagnosis of breast cancer.
This unit is intended for use in the same clinical applications as traditional screen film mammography systems.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k)Summary
[As required by 21 CFR 807.92]
K220073
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92
1. Date Prepared [21 CFR 807.92(a) (1)]
14/12/2022
2. Submitter's Information [21 CFR 807.92(a) (1)]
| • Name of Sponsor: | DRTECH Corporation |
|---|---|
| • Address: | Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil,Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea |
| • Contact Name: | Suyeon, Back |
| • Telephone No.: | + 82-31-779-7727 |
| • Fax No.: | + 82-31-779-7790 |
- Email Address : ● syback@drtech.co.kr
- Registration Number: 3005172103
- Name of Manufacturer: ● Same as Sponsor
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]
| • Trade Name: | RMF-2000 |
|---|---|
| • Common Name: | Digital Mammography system |
| • Classification Name: | Full Field Digital, System, X-ray, Mammographic |
| • Classification Panel: | Radiology |
| • Classification Regulation: | 21 CFR 892.1725 |
| • Product Code: | MUE |
| • Device Class: | II |
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4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
(1) Predicate Device
●
- 510(k) Number: K110798
- GENERAL ELECTRIC COMPANY Applicant: .
- Trade Name: SENOGRAPHE DS ●
- Classification Name: ● Full Field Digital, System, X-ray, Mammographic
- . Classification Panel: Radiology
- . Classification Regulation: 21 CFR 892.1715
- Product Code: MUE .
- Device Class: II ●
(2) Reference Device
- PMA Number: P010025
- Applicant: Hologic, Inc.
- Trade Name: Selenia Dimensions .
- . Classification Name: Full Field Digital, System, X-ray, Mammographic
- Classification Panel: Radiology .
- Classification Regulation: 21 CFR 892.1715
- Product Code: ● MUE
- Device Class: II ●
5. Description of the Device [21 CFR 807.92(a) (4)]
The system consists of a gantry with integrated high-voltage generator as well as an optional radiation shield with a height-adjustable control desk with an integrated Acquisition Workstation (AWS). The moveable swivel C-arm on the gantry contains the X-ray tube on the top end and the breast support with the X-ray detector on the bottom end. The detector is a full field digital mammography detector.
RMF-2000 acquires digital mammographic images for diagnosis of the breast cancer. RMF-2000 is designed to be used in the same clinical application for 2D screening mammographic systems. The screening examination exposes X-rays to the left and the right breasts of the patient to acquire images. Also, the RMF-2000 can be used to additional precision diagnosis for breasts.
The device's software provides an integrated solution for X-ray projection. It integrates with the X-ray generator and the digital detector and acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system, and print images through the DICOM printer.
6. Indication for Use [21 CFR 807.92(a)(5)]
The RMF-2000 generates 2D digital mammography images. The RMF-2000 is intended to be used for screening and diagnosis of breast cancer.
This unit is intended for use in the same clinical applications as traditional screen film mammography systems.
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7. Technological Characteristics [21 CFR 807.92(a)(6)]
RMF-2000 system is a Full-Field Digital Mammography in which the X-ray film is replaced by proven X-ray detector technology with smallest 76um (indirect) and 65um (direct) pixel size.
With a built-in generator, RMF-2000 is easy to install in small spaces as there is no need for a separate generator compartment.
Using two parameter of thickness and density, which are able to get when a patient takes an x-ray image, according to patient's breast type calculate optimal dose automatically to provide a uniform, high-quality mammogram.
Reliable and precise automatic exposure control perfectly optimizes and determines the exposure parameters in accordance with each patient's breast characteristics with AEC and Dual Filter technology.
Collimator setting is changed automatically for each different paddle barcode recognition system.
With the auto-positioning function, the screening protocol set during patient registration is automatically recognized by the system to quickly and easily set the next screening position. The system maintains the patient height information, so no additional height adjustment is required.
| Parameter | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| 510(K)Number | Unknown | K110798 | - |
| Manufacturer | DRTECH Corporation | GENERAL ELECTRICCOMPANY | - |
| Model Name | RMF-2000 | SENOGRAPHE DS | - |
| ClassificationName | Full Field Digital, System,X-ray, MammographicRadiology | Full Field Digital, System,X-ray, MammographicRadiology | Same |
| ClassificationPanel | Same | ||
| ClassificationRegulation | 21 CFR 892.1715 | 21 CFR 892.1715 | Same |
| Product Code | MUE | MUE | Same |
| Device Class | Class II | Class II | Same |
| Intended Use | The RMF-2000 generates2D digital mammographyimages. The RMF-2000 isintended to be used forscreening and diagnosis ofbreast cancer.This unit is intended for usein the same clinicalapplications as traditionalscreen film mammographysystems. | The Senographe DS andSenographe Essential FFDMsystems generate digitalmammographic images thatcan be used for screening andin the diagnosis of breastcancer. The Senographe DSand Senographe EssentialFFDM systems are intendedto be used in the same clinicalapplications as traditionalfilm-based mammographicsystems. | Same |
| Patientpopulation | Age : Adult for the purposeof mammography screening | Age : Adult for the purposeof mammography screening | Same |
| Design | Detector Size : 240 x | Detector Size : 240 x | Same |
| 300mm | 300mm | ||
| Pixel Pitch-RSM 2430UDP: 65um-RSM 2430TD: 76um | Pixel Pitch100um | Higher:Pixel pitchis smallerthanpredicatedevice | |
| Resolution-RSM 2430 UDP: 4,608 x3,584-RSM 2430TD: 3,840 x3,072 | Resolution2,294 x 1,914 | Higher | |
| MaterialsScintillator | RSM 2430 UDP (Selenium)RSM 2430TD (CsI) | CsI | Same orHigher |
| DetectorType | RSM 2430 UDP: a-SeRSM 2430TD : amorphoussilicon with CsI scintillator | CsI | Same orHigher:Wide inputvoltagerangeRMF-2000complieswithIEC60601-1 andIEC60601-2-45. |
| Power supply | Single-Phase, Input voltage200-240 Vac (±10%) | Single-phase input voltage:200/208/220/240 V (±10%) | Higher:Wide inputvoltagerangeRMF-2000complieswithIEC60601-1 andIEC60601-2-45. |
| Exposuremode | AEC (Automatic ExposureControl), Manual | AOP(AutomaticOptimizationof Parameters) Manual | Same, AECand AOParecalculateoptimizedX-rayexposureparameter |
| GeneratorType | High Frequency | High Frequency | Same |
| BreastCompressionSystem | Maximum Compression thatcan be applied (N)Motor driven: 200Manual: 30 | Maximum Compression thatcan be applied (N)Motor driven: 200Manual: 30 | Same |
| SID | 660mm | 660mm | Same |
| DICOM | DICOM Services, SCU,Storage Commitment,MPPS, worklistmanagement SCU,structured report,media storage, print | DICOM Services, SCU,Storage Commitment,MPPS, worklistmanagement SCU,structured report,media storage, print | Same |
8. Substantial Equivalence [21 CFR 807.92(b)]
510(k) Summary
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510(k) Summary
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The predicate device (K110798) and the subject device, RMF-2000 are equivalent in terms of the following matters:
- Intended Use
- Patient population
- Detector size
- Exposure mode
- Generator Type
- · Breast Compression System
- SID
- DICOM
A few differences are as follows
- Pixel Pitch
- Resolution
- · Materials Scintillator
- Detector Type
- Power supply
There is no significant difference between the RMF-2000 and the predicate device that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate device.
Even though the predicate device and the subject device differ, the differences are not critical in terms of the diagnostic purposes because the clinical image evaluation demonstrate that the subject devices are substantially equivalent to the predicate device.
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| Parameter | Subject Device | Reference Device | Remark | |
|---|---|---|---|---|
| Manufacturer | DRTECH Corporation | Hologic | - | |
| Model Name | RMF-2000 | Selenia Dimensions | - | |
| PMA Number | - | P010025 | - | |
| ClassificationName | Full Field Digital, System, X-ray, Mammographic | Same | ||
| ClassificationPanel | Radiology | Same | ||
| ClassificationRegulation | 21 CFR 892.1715 | Same | ||
| Product Code | MUE | Same | ||
| Device Class | Class II | Same | ||
| Intended Use | The RMF-2000 generates2D digital mammographyimages. The RMF-2000 isintended to be used forscreening and diagnosis ofbreast cancer.This unit is intended for usein the same clinicalapplications as traditionalscreen film mammographysystems. | The Hologic SeleniaDimensions generates digitalmammographic images thatcan be used for screening anddiagnosis of breast cancer.The Selenia Dimensionssystem is intended for use inthe same clinicalapplications as Full FieldDigital Mammographysystems for screeningmammograms. | Same | |
| Design | DetectorSize | 240 x 300mm | 240 x 290mm | Same orHigher |
| PixelPitch | 65um | 70um | Same orHigher | |
| Resolution | 4,608x 3,584 | 3,328x 4,096 | Same orHigher | |
| MaterialsScintillator | a Se direct.RSM 2430 UDP (Selenium) | a Se direct. | Same | |
| TFT | Amorphous Selenium | Amorphous Selenium | Same |
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| Exposuremode | AEC (Automatic ExposureControl), Manual | AEC (Automatic ExposureControl), Manual | Same |
|---|---|---|---|
| AnatomicalSites | Breast | Breast | Same |
| CommunicationMethod | Wire | Wire | Same |
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9. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]
The RMF-2000 introduces no new safety or efficacy issues other than those already identified with the predicate device. To demonstrate the safety and effectiveness of RMF-2000 and to demonstrate substantial equivalence to the predicate device, RMF-2000 has completed the following non-clinical tests. This confirms that the design inputs and performance specifications of this equipment have been met. The RMF-2000 has been tested according to internal requirements, national standards and international standards indicated below to support safety and effectiveness and substantial equivalence to predicate device.
The RMF-2000 complies with the following international and FDA-recognized consensus standards:
| AAMI ANSI ES60601-1: Medical Electrical Equipment -- Part 1: General Requirements for BasicSafety and Essential Performance (IEC 60601- 1:2005, Mod) | |
|---|---|
| IEC 60601-1-2: | Medical Electrical Equipment - Part 1-2: General Requirements For BasicSafety And Essential Performance - Collateral Standard: ElectromagneticCompatibility - Requirements And Tests (Edition 4) |
| ISO 14971: | Medical Devices - Application of Risk Management to Medical Devices.(Second edition) |
| IEC 60601-2-45: | Medical electrical equipment - Part 2-45: Particular requirements for thebasic safety and essential performance of mammographic X-ray equipmentand mammographic stereotactic devices (Edition 3.1) |
| IEC 62304: | Medical device software - Software life cycle processes |
| IEC 60601-1-3: | Medical electrical equipment - Part 1-3: General requirements for basicsafety and essential performance - Collateral Standard: Radiationprotection in diagnostic X-ray equipment (Edition 2.1) |
| IEC 60601-1-6: | Medical electrical equipment - Part 1-6: General requirements for basicsafety and essential performance - Collateral standard: Usability |
| IEC 62220-1-2: | Medical electrical equipment - Characteristics of digital X-ray imagingdevices - Part 1-2: Determination of the detective quantum efficiency -Detectors used in mammography |
| ISO 10993-1: | Biological evaluation of medical devices - Part 1: Evaluation and testingwithin a risk management process |
| ISO 10993-5: | Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity (Third edition) |
| ISO 10993-10: | Biological evaluation of medical devices - Part 10: Tests for irritation andskin sensitization (Third edition) |
| ISO 15223-1: | Symbols to be used with medical device labels, labeling and information tobe supplied |
And RMF-2000 complies with the FDA guidance document entitled 'Class II Special Controls Guidance Document: Full-Field Digital Mammography System, ' March 27, 2012.
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10. Summary of Clinical Data [21 CFR 807.92(b)(2)]
A clinical image evaluation in accordance with the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System issued on April 4, 2012 (Section 9 Clinical Image Evaluation) was conducted with the RMF-2000 and determined that the images, reviewed by MQSA qualified interpreting physicians, were of sufficiently acceptable quality for mammographic usage and that the images are substantially equivalent to those from predicate device.
11. Conclusion [21 CFR 807.92(b)(3)|
The RMF-2000 is substantially equivalent to the currently marketed predicate device in terms of design, fundamental scientific technology, and indications for use, safety, and effectiveness.
Substantial equivalence for Digital Mammography system (RMF-2000) was demonstrated through the non-clinical performance in compliance with the requirements specified in the international and FDA recognized consensus standards, AAMI ANSI ES60601-1, IEC 60601-1-2, ISO 14971, IEC 60601-2-45, IEC 62304, IEC 60601-1-3, IEC 60601-1-6, IEC 62220-1-2, A AMI ANSI ISO 10993-1, ISO 10993-5, and ISO 10993-10.
Also, substantial equivalence was demonstrated through a clinical test, which was conducted in accordance with in the "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System".
The results of these tests demonstrate that the RMF-2000 meets the acceptance criteria, and the device is adequate for its intended use.
The comparison of technological characteristics, non-clinical performance data, safety testing, and clinical image concurrence data demonstrate that the RMF-2000 is substantially equivalent to the predicate device.
§ 892.1715 Full-field digital mammography system.
(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.