(27 days)
Not Found
No
The summary describes standard digital X-ray image processing and does not mention any AI or ML components. The focus is on hardware updates and basic software functions.
No.
The GM85 Digital Mobile X-ray Imaging System is used to capture radiographic images which are used for diagnosis, not for therapeutic purposes.
Yes
The device is described as an "X-ray Imaging System" that generates "radiographic images of human anatomy" to be "read" by "professional radiologists," indicating its role in producing images for diagnosis. The "S-Station" is explicitly called the "Operation Software (OS) of Samsung Digital Diagnostic X-ray System."
No
The device description explicitly states it is an "X-ray Imaging System" that transmits X-rays, uses a detector to convert signals, and involves hardware components like the S-Station. While it includes software (S-Station Operation Software and Image Post-processing Engine), it is fundamentally a hardware-based imaging system with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The GM85 Digital Mobile X-ray Imaging System generates radiographic images by transmitting X-rays through the human body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "generating radiographic images of human anatomy." This is a form of in vivo (within the living body) imaging, not in vitro.
- Device Description: The description details the process of X-rays passing through the patient and being captured by a detector, which is consistent with in vivo imaging.
The device is a medical imaging system used for diagnostic purposes, but it operates by interacting directly with the patient's body, not by analyzing samples outside of it.
N/A
Intended Use / Indications for Use
The GM85 Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Product codes
IZL
Device Description
The GM85 Digital Mobile X-ray Imaging System is used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the S-Station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-Station, and send to the Picture Archiving & Communication System (PACS) sever for reading images.
The GM85 Digital Mobile X-ray imaging System was previously cleared with K222353, and through this premarket notification, we would like to add more configurations in the previously cleared GM85 as a detector, accessories are newly added and software is updated for user convenience.
The new detector added in the proposed device is designed to achieve a higher IP rating of Dust and Water and reduce weight while maintaining durability, functionality and operation like the detector of the predicate device. The new detector and predicate device's detector are both an x-ray conversion device using an amorphous silicon flat panel and absorb incident x-rays, converts it to a digital signal, and then transmits it to the Samsung Digital X-ray System like that of the predicate device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained doctor or technician
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)
Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO 14971, 21 CFR1020.30 and 21 CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards.
Non-clinical data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1.
The proposed device has a new detector that has equivalent image characteristics as the existing ones. Specific description is added to make it clear with the non-clinical data and phantom image evaluation report. And this detector is evaluated by Software System Test Case for verification and validation.
Phantom image evaluation of the new detector was performed in accordance with FDA quidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. Anthropomorphic phantom images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (note X-ray flat-panel detector similar to the predicate detector) but they provide further evidence in addition to the performance data to show that the complete system works as intended. They were evaluated by professional radiologists and found to be equivalent to the predicate devices. There is no significant difference in the average score of image quality evaluation between the proposed device and the predicate device. Therefore, this change does not affect either the safety or the effectiveness, compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
High Contrast Limiting Resolution (LP/mm): 3.57
DQE (Detective Quantum Efficiency): 76% (0lp/mm, Typical)
MTF (Modulation Transfer Function): 86% (0.5lp/mm, Typical)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. 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 the logo of the U.S. Food and Drug Administration (FDA). On the left 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.
October 1, 2024
SAMSUNG ELECTRONICS Co., Ltd. % Jaesang Noh Regulatory Affairs, Principal Professional 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 16677 SOUTH KOREA
Re: K242651
Trade/Device Name: Gm85 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: August 30, 2024 Received: September 4, 2024
Dear Jaesang Noh:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242651
Device Name GM85
Indications for Use (Describe)
The GM85 Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Type of Use (Select one or both, as applicable)
| Transactional Use (Permitted under SEC Rule 15c3-5, as amended) |
|---|
| Non-Transactional Use |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
SAMSUNG
510(k) Premarket Notification - Special
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92
-
- Date: August 30, 2024
2. Submitter
- A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, Republic of Korea
3. Primary Contact Person
- A. Name: JAESANG NOH
- B. Title: Regulatory Affairs, Principal Professional
- C. Phone Number: +82-2-2193-2444
- D. FAX Number: +82-2-2194-0284
- E-Mail: jaesang.noh@samsung.com ய்
4. Secondary Contact Person
- A. Name: Ninad Gujar
- B. Title: Vice President, Regulatory Affairs & Quality Control
- C. Phone Number: 978-564-8503
- D. FAX Number: 978-560-0602
- E. E-Mail: ngujar@neurologica.com
5. Proposed Device
- A. Trade Name: GM85
- B. Device Name: GM85
- C. Common Name: Digital Diagnostic Mobile X-ray System
- D. Classification Name: Mobile X-ray System
- E. Product Code: IZL
- ட் Regulation: 21 CFR 892.1720
6. Predicate Devices
| Predicate Device | |
|---|---|
| Device Name | GM85 |
| Classification Name | Mobile X-ray system. |
| Product Code | IZL |
| Regulation | 21 CFR 892.1720 |
| 510(k)# | K222353 |
| 510(K) Decision Date | September 29, 2022 |
5
510(k) Premarket Notification - Special
7. Device Description
The GM85 Digital Mobile X-ray Imaging System is used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the S-Station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-Station, and send to the Picture Archiving & Communication System (PACS) sever for reading images.
The GM85 Digital Mobile X-ray imaging System was previously cleared with K222353, and through this premarket notification, we would like to add more configurations in the previously cleared GM85 as a detector, accessories are newly added and software is updated for user convenience.
The new detector added in the proposed device is designed to achieve a higher IP rating of Dust and Water and reduce weight while maintaining durability, functionality and operation like the detector of the predicate device. The new detector and predicate device's detector are both an x-ray conversion device using an amorphous silicon flat panel and absorb incident x-rays, converts it to a digital signal, and then transmits it to the Samsung Digital X-ray System like that of the predicate device.
8. Intended Use
The GM85 Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
9. Summary of Technological characteristic of the proposed device compared with the predicate device
The proposed device, GM85, has the same technological characteristics and hardware as its original predicate device, GM85 (K222353). There are some differences but, they do not have significant changes in energy source or technological characteristics compared to the predicate device.
Comparisons of technological characteristics were executed and demonstrate the substantial equivalence to the predicate device.
| Attribute | Proposed Device
(GM85) | Predicate Device
(GM85, K222353) | Comparison
Results |
|---------------|---------------------------|-------------------------------------|-----------------------|
| Device Name | GM85 | GM85 | - |
| Manufacturer | SAMSUNG
ELECTRONICS | SAMSUNG
ELECTRONICS | - |
| 510(k) Number | - | K222353 | - |
- A. Comparing with Predicate Device
6
SAMSUNG
510(k) Premarket Notification - Special
| Attribute | Proposed Device
(GM85) | | Predicate Device
(GM85, K222353) | | Comparison
Results | | | |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Appearances | Image: [C-Type*]
[C-Type*]
Collapsib
le column
type with
an
automatic
collimator
(C-Type) | Image: [F-Type*]
[F-Type**]
Fixed
column
type with
a manual
collimator
(F-Type) | Image: [Fit-Type*]
[Fit-Type***]
Collaps
ible
column
type a
manual
collimator
(Fit-Type) | Image: [C-Type]
[C-Type]
Collapsib
le column
type with
an
automatic
collimator
(C-Type) | Image: [F-Type]
[F-Type**]
Fixed
column
type with
a manual
collimator
(F-Type) | Image: [Fit-Type*]
[Fit-Type***]
***Collaps
ible
column
type a
manual
collimator
(Fit-Type) | Same | |
| Indications for Use | The GM85 Digital Mobile
X-ray Imaging System is
intended for use in
generating radiographic
images of human anatomy
by a qualified/trained
doctor or technician. This
device is not intended for
mammographic
applications | | | | | | The GM85 Digital Mobile
X-ray Imaging System is
intended for use in
generating radiographic
images of human anatomy
by a qualified/trained
doctor or technician. This
device is not intended for
mammographic
applications | Same |
| Attribute | Proposed Device
(GM85) | Predicate Device
(GM85, K222353) | Comparison
Results |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| (1) Detector | | | |
| Name | S4335-W
S4343-W
S3025-W
S4335-AW
S4343-AW
S4335-AWM
S4343-AWM
S3025-AW
S3025-AWM
F4335-AW
F4343-AW
F4343-AW | S4335-W
S4343-W
S3025-W
S4335-AW
S4343-AW
S4335-AWM
S4343-AWM
S3025-AW
S3025-AWM
F4335-AW
S4343-AW | Difference (1) |
| Detector Type | Csl
Indirect | Csl
Indirect | Same |
| Detector Area | 17"X17"
(425mmX425mm) | 17"X17"
(425mmX425mm) | Same |
| Number of pixels | 3036X3040 | 3036X3040 | Same |
| Pixel Pitch(um) | 140 | 140 | Same |
| High Contrast Limiting
Resolution (LP/mm) | 3.57 | 3.57 | Same |
| Communication | Wired / Wireless | Wired / Wireless | Same |
| Dust/Water-resistance | IP57 | IP54 | Difference (1)-1 |
| Max.load capacity
(uniform load / local
load,, | 400 kg/200 kg | 400 kg/200 kg | Same |
7
SAMSUNG
510(k) Premarket Notification - Special
| Attribute | Proposed Device
(GM85) | Predicate Device
(GM85, K222353) | Comparison
Results |
|------------------------------------------|----------------------------|-------------------------------------|-----------------------|
| (1) Detector | | | |
| at the center) | | | |
| DQE
(Detective Quantum
Efficiency) | 76%
(0lp/mm, Typical) | 76%
(0lp/mm, Typical) | Same |
| MTF
(Modulation Transfer
Function) | 86%
(0.5lp/mm, Typical) | 86%
(0.5lp/mm, Typical) | Same |
| Weight
(w/o Battery Set) | Approx. 2.5 kg | Approx. 3.4 kg | Difference (1)-2 |
| Attribute | Proposed Device
(GM85) | Predicate Device
(GM85, K222353) | Comparison
Results | |
|--------------------------------|---------------------------|----------------------------------------------------------|-----------------------------------------|------------------|
| (2) Accessories | | | | |
| Wireless
Exposure
Switch | Name | TS_CES(SAM)
C2UW-LP-I
SDR-OGRC30K
CAPE H301W-S1 | TS_CES(SAM)
C2UW-LP-I
SDR-OGRC30K | Difference (2)-1 |
| | Types | Infra-red Bluetooth | Infra-red Bluetooth | Same |
| RFID
reader | Name | pcProx
RDR-80031BKU V2 | pcProx | Difference (2)-2 |
| | Type | USB Type | USB Type | Same |
| | Transmit
Frequency | 125kHz, 13.56 MHz | 125kHz, 13.56 MHz | Same |
| Attribute | Proposed Device
(GM85) | Predicate Device
(GM85, K222353) | Comparison
Results |
|-----------------------|---------------------------|-------------------------------------|-----------------------|
| (3) Software Features | | | |
| S-Share | S-Share | S-Share | Same |
| S-Enhance | S-Enhance | S-Enhance | Same |
| SimGrid | SimGrid | SimGrid | Same |
| PEM | PEM | PEM | Same |
| QAP | QAP | QAP | Same |
| Bone Suppression | Bone Suppression | Bone Suppression | Same |
| Remote View | Remote View | Remote View | Same |
| Mirror View | Mirror View | Mirror View | Same |
8
Image /page/8/Picture/1 description: The image shows the word "SAMSUNG" in blue, block letters. The font is bold and sans-serif. The letters are evenly spaced and the word is horizontally oriented.
510(k) Premarket Notification - Special
| Attribute | Proposed Device (GM85) | Predicate Device (GM85, K222353) | Comparison Results |
|---|---|---|---|
| RFID | RFID | RFID | Same |
| Value-up Package | Value-up Package | - | Difference (3) |
| No | Comparison Results | Discussion |
|---|---|---|
| (1) | Detector | A new detector (F4343-AW) is added to the GM85 device. |
| This change does not contribute any adverse impact to the | ||
| device's safety and effectiveness. | ||
| (1)-1 | Dust/Water-resistance | The IP rating of the new detector is higher than that of the |
| predicate device because the process to block any potential | ||
| water leak paths was added such as adding seals around | ||
| vulnerable areas. This change does not contribute any | ||
| adverse impact to the device's safety and diagnostic | ||
| effectiveness. | ||
| (1)-2 | Weight | |
| (w/o Battery Set) | The new detectors which are added to the GM85 device is | |
| lighter than that of the predicate device because a non- | ||
| glass substrate was used, instead of a glass substrate used | ||
| in the detector of the predicate device. The non-glass | ||
| substrate is the same one used for the detector, F4335-AW, | ||
| cleared with K222353. This change does not contribute any | ||
| adverse impact to the device's safety and diagnostic | ||
| effectiveness. | ||
| (2)-1 | Wireless Exposure | |
| Switch | A new Wireless Exposure Switch is added optionally to the | |
| GM85 device which is the same specification as those of | ||
| the predicate device. These changes do not contribute any | ||
| adverse impact to the device's safety and effectiveness. | ||
| (2)-2 | RFID reader | A RFID reader is added optionally to the GM85 device which |
| is the same specification as those of the predicate device. | ||
| These changes do not contribute any adverse impact to the | ||
| device's safety and effectiveness. | ||
| (3) | Value-up Package | Some software features which is an option to provide |
| convenience for use, called as the Value-up Package, is | ||
| applied to the GM85 device and these changes do not | ||
| contribute any adverse impact to the device's safety and | ||
| effectiveness. |
B. Safety, EMC and Performance Data
Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO 14971, 21 CFR1020.30 and 21 CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in
9
510(k) Premarket Notification - Special
Medical Devices. All test results were satisfying the standards.
- C. Non-clinical data
Non-clinical data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1.
The proposed device has a new detector that has equivalent image characteristics as the existing ones. Specific description is added to make it clear with the non-clinical data and phantom image evaluation report. And this detector is evaluated by Software System Test Case for verification and validation.
Phantom image evaluation of the new detector was performed in accordance with FDA quidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. Anthropomorphic phantom images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (note X-ray flat-panel detector similar to the predicate detector) but they provide further evidence in addition to the performance data to show that the complete system works as intended. They were evaluated by professional radiologists and found to be equivalent to the predicate devices. There is no significant difference in the average score of image quality evaluation between the proposed device and the predicate device. Therefore, this change does not affect either the safety or the effectiveness, compared to the predicate device.
-
D. Clinical data
This submission does not required clinical data. -
E. Summary of the Standards and Guidance Compliance
-
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical Electrical Equipment -Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 4.1 Medical Electrical Equipment Part 1-2: General 2. Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic compatibility - Requirements and Tests
-
- IEC 60601-1-3 Edition 2.2 Medical Electrical Equipment – Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation protection in Diagnostic X-ray Equipment
-
- IEC 60601-2-28 Edition 3 Medical Electrical Equipment - Part 2-28: Particular Requirements for the Basic Safety and Essential Performance of X-ray Tube Assemblies for Medical Diagnosis
- IEC 60601-2-54 Edition 2.0 Medical Electrical Equipment Part 2-54: particular 5. Requirements for the Basic Safety and Essential Performance of X-ray Equipment for Radiography and Radioscopy
- IEC 62220-1-1 Edition 1.0 Medical electrical Equipment Characteristics of digital 6. X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging
- Cybersecurity in Medical Device: Quality System Considerations and Content of 7. Premarket Submissions issued on September 27, 2023
-
10
510(k) Premarket Notification - Special
-
- Content of Premarket Submissions for Device software Functions issued on June 14, 2023
-
- Guidance for the Submission for 510(k) for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff issued on September 1, 2016
-
- Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff issued on November 28, 2017
- F. Conclusions
The non-clinical data demonstrates that the proposed device is as safe, as effective, and performs as well as the legally marketed devices.