(94 days)
Yes
The summary explicitly mentions "Compatibility with the already FDA cleared CA-100S / FluoroShield AI Exposure Reduction Technology" and "Integration of a New Flat Panel Detector... with the already FDA cleared FluoroShield AI Exposure Reduction Technology." This indicates that the device is designed to integrate with a component that utilizes AI technology.
No.
The device is an image processor for radiographic/fluoroscopic applications, providing imaging information for minimally invasive interventional procedures, but it does not directly deliver therapy or treat a condition.
Yes
The device is an image processor used in radiographic/fluoroscopic applications including diagnostic x-ray imaging, providing real-time image visualization of patient anatomy and post-processing functions. This information is used by physicians to diagnose conditions.
No
The device is described as a "dynamic digital image processing system" that functions on a "PC based CPU" and "interfaces, with to acquire and digitize x-ray exposure". While it is software-based, it is explicitly stated to be a "component" of a larger hardware system (Omega CS-series-FP platform) and interacts directly with hardware components like flat panel detectors to acquire and process images. This indicates it is not a standalone software-only device.
Based on the provided text, the Omega Medical Imaging, LLC Nyquist.IQ Image Processor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states "Radiographic/fluoroscopic applications including cardiac, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging." This describes imaging procedures performed on a patient, not tests performed on biological samples outside the body.
- Device Description: The description focuses on image processing of x-ray exposures acquired from a flat panel detector. This is consistent with medical imaging equipment used for diagnosis and intervention in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Nyquist.IQ Image Processor is a medical imaging device used for diagnostic and interventional procedures, not an in vitro diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device; it only mentions "Control Plan Authorized (PCCP) and relevant text: Not Found".
Intended Use / Indications for Use
The Omega Medical Imaging, LLC Nyquist.IQ Image Processor is intended for use in Radiographic/fluoroscopic applications including cardiac, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging. The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP Systems.
Product codes (comma separated list FDA assigned to the subject device)
JAA, MQB
Device Description
Nyquist.IQ is a dynamic digital image processing system. The system application is based on a PC Windows operating system functioning on a PC based CPU. The object-oriented software performs real-time image processing and full procedure storage. The DICOM compliant connectivity provides the tools to transmit patient demographics, examination, and image data digitally.
Nyquist.IQ is not a standalone device, but functions as a component for FDA cleared Omega CS-series-FP platform. Nyquist IQ is an image processor that interfaces, with to acquire and digitize x-ray exposure from the Omega medical CS-series-FP.
The Nyquist.IQ operates in connection with the Varex's 3030 or the Teledyne 3030 flat panel detectors. This is demonstrated in the substantial equivalence section of the Nyquist.IQ is intended for the Omega CS-series-FP with Optional Accessory Device CA-100S / FluoroShield platform.
The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP systems.
The Nyquist.IQ image processor. The fundamental performance characteristics of the Nyquist.IQ interventional fluoroscopic imaging Processor system consists of:
- ) Real-time image visualization of patient anatomy during procedures
-
Imaging techniques and tools to assist interventional procedures.
- 2 Post-processing functions after interventional procedures.
- 2 Storage of reference/control images for patient records.
- Σ Compatibility to images of other modalities via DICOM
- 2 Compatibility with the already FDA cleared CA-100S / FluoroShield AI Exposure Reduction Technology. (K182834)
This array of functions provides the physician the imaging information required to achieve minimally invasive interventional procedures.
The Nyquist.IQ image processor is available as a Model IPS-100 configuration and is similar to the currently marketed and predicate image processor MX-200 in CS-series-FP with optional CA-100S / FluoroShield Device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes (The Nyquist.IQ system has compatibility with the already FDA cleared CA-100S / FluoroShield AI Exposure Reduction Technology.)
Input Imaging Modality
X-ray (Radiographic/fluoroscopic)
Anatomical Site
Not Found
Indicated Patient Age Range
General Population, special concerns must be taken for pediatric use.
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)
Non-clinical performance testing has been performed on the Nyquist.IQ Image processor and demonstrated compliance with the following International and FDA approved consensus standard and FDA guidance documents:
-
- IEC 62304 Medical device software Software life cycle processes (Edition 1.1, 2015-06). FDA/CDRH recognition number 13-79.
-
- ISO 14971 Medical devices Application of risk management to medical devices (Edition 2.0, 2007-03-01). FDA/CDRH recognition number 5-40.
-
- Guidance for Industry and FDA Staff Guidance for the Content of premarket Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337).
-
- "Guidance for Industry and FDA Staff The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", July 28, 2014 (document number 1766).
Software verification testing of the functional and non-functional requirements, as well as performance, reliability, and safety, have been performed to verify that all conditions of System requirements Specifications, as well as the safety risk control measures from the detailed Risk management and the privacy and security requirements, have been implemented. Results demonstrated that executed verification test was passed.
Non- clinical validation testing has been performed to validate that the Nyquist.IQ Image Processor conforms to the intended use, claims, user, and service needs, effectively satisfying measures and instruction for use.
The Nyquist.IQ did not require clinical study data since substantial equivalence to the currently marketed predicate device Omega CS-series-FP with Optional Accessory Device CA-100S / FluoroShield was demonstrated with the following attributes:
- Σ Indication for use.
- A Technological characteristics.
- ) Non-clinical performance testing; and
- ∑ Safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
December 13, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Omega Medical Imaging, LLC % Mr. John Newman Regulatory Specialist 3400 St. Johns Parkway, Suite 1020 SANFORD FL 32771
Re: K212890
Trade/Device Name: Nyquist.IO Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified Fluoroscopic X-ray System Regulatory Class: Class II Product Code: JAA, MQB Dated: November 10, 2021 Received: November 12, 2021
Dear John Newman:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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,
Digitally signed by
Laurel M. Burk -S
Date: 2021.12.13
13:53:02 -05'00'
. for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212890
Device Name Nyquist.IQ
Indications for Use (Describe)
The Omega Medical Imaging, LLC Nyquist.IQ Image Processor is intended for use in Radiographic/fluoroscopic applications including cardiac, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging. The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP 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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Image /page/3/Picture/0 description: The image contains the logo for Omega Medical Imaging. The logo consists of a stylized blue "O" shape on the left, followed by the word "OMEGA" in blue, block letters. Below the word "OMEGA" is the phrase "Medical Imaging" in a smaller, lighter font, also in blue. The overall design is clean and professional, suggesting a company in the healthcare or medical technology sector.
| Traditional 510(k) SUMMARY K212890 | |
|---|---|
| Company Name: | Omega Medical Imaging, LLC |
| Address: | 3400 St. Johns Parkway, Suite 1020, Sanford, FI 32771 |
| Telephone No: | 407-323-9400 |
| Registration No: | 1052701 |
| Contact person: | John Newman (Regulatory Affairs Specialist) |
| Date Prepared: | 09/02/2021 |
| Device (trade) name: | Nyquist.IQ |
| Common/usual name: | Image Processor |
| Classification Name: | Image Processor |
| Classification Panel: | Radiology |
| CFR section: | 892.1650 |
| Device Class: | Class II |
| Primary Product code: | JAA |
| Secondary product code: | MQB |
| Predicate Device K182834 | |
| Company Name: | Omega Medical Imaging, LLC |
| Address: | 3400 St. Johns Parkway, Suite 1020 |
| Telephone No: | 407-323-9400 |
| Registration No: | 1052701 |
| Contact person: | John Newman |
| Date Prepared: | 03/29/2019 |
| Device (trade) name: | CS-series-FP with Optional Accessory Device CA-100S (FluoroShield |
| Common/usual name: | Fluoroscopic/Radiographic X-ray system |
| Classification Name: | System, X-Ray, Fluoroscopic, Image -Intensified |
| Classification Panel: | Radiology |
| CFR section: | 892.1650 |
| Device Class: | Class II |
| Primary Product code: | JAA |
| Secondary Product code: | OWB |
| Company Name: | Omega Medical Imaging, LLC |
| Address: | 675 Hickman Circle, Sanford, FI 32771 |
| Telephone No: | 407-323-9400 |
| Registration No: | 1052701 |
| Contact person: | John Newman |
| Date Prepared: | 04/20/2012 |
| Device (trade) name: | CS-series-FP with 3030+ Option |
| Common/usual name: | Fluoroscopic/Radiographic X-ray system |
| Classification Name: | System, X-Ray, Fluoroscopic, Image -Intensified |
| Classification Panel: | Radiology |
| CFR section: | 892.1650 |
| Device Class: | Class II |
| Primary Product codes: | JAA |
| Secondary Product code: | OWB |
4
Reference Predicate Device K121293
Indication of use:
The Omega Medical Imaging, LLC IPS-100, Nyquist.IQ Image Processor is intended for use in Radiographic/fluoroscopic applications including cardiac, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging
The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP systems.
Device description:
Nyquist.IQ is a dynamic digital image processing system. The system application is based on a PC Windows operating system functioning on a PC based CPU. The object-oriented software performs real-time image processing and full procedure storage. The DICOM compliant connectivity provides the tools to transmit patient demographics, examination, and image data digitally.
Nyquist.IQ is not a standalone device, but functions as a component for FDA cleared Omega CS-series-FP platform. Nyquist IQ is an image processor that interfaces, with to acquire and digitize x-ray exposure from the Omega medical CS-series-FP.
The Nyquist.IQ operates in connection with the Varex's 3030 or the Teledyne 3030 flat panel detectors. This is demonstrated in the substantial equivalence section of the Nyquist.IQ is intended for the Omega CS-series-FP with Optional Accessory Device CA-100S / FluoroShield platform.
5
The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP systems.
The Nyquist.IQ image processor. The fundamental performance characteristics of the Nyquist.IQ interventional fluoroscopic imaging Processor system consists of:
- ) Real-time image visualization of patient anatomy during procedures
-
Imaging techniques and tools to assist interventional procedures.
- 2 Post-processing functions after interventional procedures.
- 2 Storage of reference/control images for patient records.
- Σ Compatibility to images of other modalities via DICOM
- 2 Compatibility with the already FDA cleared CA-100S / FluoroShield AI Exposure Reduction Technology. (K182834)
This array of functions provides the physician the imaging information required to achieve minimally invasive interventional procedures.
The Nyquist.IQ image processor is available as a Model IPS-100 configuration and is similar to the currently marketed and predicate image processor MX-200 in CS-series-FP with optional CA-100S / FluoroShield Device.
Patient Population:
General Population, special concerns must be taken for pediatric use.
Based on the information provided above, the Nyquist.IQ system is considered substantially equivalent to the current marketed predicate device CS- series-FP with optional CA-100S / FluoroShield Device. Both share the same Indications for use.
Technological characteristics
The Nyquist.IQ system has similar technological characteristics compared to the predicate device with some improvements to it. Below are the key improvements between the new Nyquist.IQ image processor and the predicate device.
- 2 Integration of a New Flat Panel Detector (Teledyne Xineos 3030HS CMOS x-ray detector) with the already FDA cleared FluoroShield AI Exposure Reduction Technology.
The difference between the Nyquist.IQ system and the predicate device does not raise any new question regarding safety or effectiveness. Based on the information provided in this 510K submission, Nyquist.IQ is considered substantially equivalent to the current marketed predicate CS-series-FP with optional CA-100S / FluoroShield Device in terms of fundamental technology
6
Summary of Non- Clinical Performance
Non-clinical performance testing has been performed on the Nyquist.IQ Image processor and demonstrated compliance with the following International and FDA approved consensus standard and FDA guidance documents:
-
- IEC 62304 Medical device software Software life cycle processes (Edition 1.1, 2015-06). FDA/CDRH recognition number 13-79.
-
- ISO 14971 Medical devices Application of risk management to medical devices (Edition 2.0, 2007-03-01). FDA/CDRH recognition number 5-40.
-
- Guidance for Industry and FDA Staff Guidance for the Content of premarket Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337).
-
- "Guidance for Industry and FDA Staff The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", July 28, 2014 (document number 1766).
Software verification testing of the functional and non-functional requirements, as well as performance, reliability, and safety, have been performed to verify that all conditions of System requirements Specifications, as well as the safety risk control measures from the detailed Risk management and the privacy and security requirements, have been implemented. Results demonstrated that executed verification test was passed.
Non- clinical validation testing has been performed to validate that the Nyquist.IQ Image Processor conforms to the intended use, claims, user, and service needs, effectively satisfying measures and instruction for use.
The Nyquist.IQ did not require clinical study data since substantial equivalence to the currently marketed predicate device Omega CS-series-FP with Optional Accessory Device CA-100S / FluoroShield was demonstrated with the following attributes:
- Σ Indication for use.
- A Technological characteristics.
- ) Non-clinical performance testing; and
- ∑ Safety and effectiveness.
Substantial equivalence Conclusion:
The Nyquist.IQ system is substantially equivalent to the currently marketed predicate device CS- series- with the Optional Accessory Device CA-100S / FluoroShield in terms of indications for use, technological characteristics, safety and effectiveness.
The Nyquist.IQ Image Processor is within the controls and predetermined specifications. Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in these 510(k) premarket notifications. These tests demonstrate that the Nyquist.IQ system complies with the user need requirements and the requirements specified in the FDA-recognized consensus standards and guidance documents.
Therefore, Nyquist.IQ is as safe and effective as its predicate device and does not raise any new safety and/or effectiveness concerns.
7
Comparison with Predicate Devices:
| Indications for use comparison: | |||
|---|---|---|---|
| 510(k) | |||
| Number and | |||
| Device | |||
| Name | K121293 (Ref. Predicate | ||
| Device) | K182834 (Predicate Device) | (This Submission) | |
| CS-series-FP with 3030+ | |||
| option | CS-series-FP with Optional | ||
| Accessory Device CA-100S / | |||
| FluoroShield | Nyquist.IQ | ||
| Intended | |||
| Use | The Omega Medical | ||
| Imaging, LLC CS-series-FP | |||
| with 3030+ Option systems | |||
| are intended for use in | |||
| radiographic/fluoroscopic | |||
| applications including | |||
| cardiac, vascular, general | |||
| radiographic/fluoroscopic | |||
| diagnostic, and | |||
| interventional X-Ray | |||
| imaging. | The Omega Medical Imaging, | ||
| LLC CS-series-FP (SSXI) | |||
| systems with optional accessory | |||
| device CA-100S as a | |||
| modification device to provide an | |||
| automated Region of interest that | |||
| manages exposure to the patient | |||
| and operator. The system is | |||
| intended for use in | |||
| Radiographic/fluoroscopic | |||
| applications including cardiac, | |||
| vascular, general radiographic/ | |||
| fluoroscopic diagnostic, and | |||
| interventional x-ray imaging for | |||
| General Populations. At no time | |||
| will the CA-100S be considered | |||
| as a replacement for the primary | |||
| collimator. The primary collimator | |||
| shall always be used, in | |||
| accordance with good medical | |||
| practice, to define a Region of | |||
| Interest | The Omega Medical Imaging, | ||
| LLC IPS-100, Nyquist.IQ Image | |||
| Processor is intended for use in | |||
| Radiographic/fluoroscopic | |||
| applications including cardiac, | |||
| vascular, general | |||
| radiographic/fluoroscopic | |||
| diagnostic, and interventional X- | |||
| Ray imaging. | |||
| (The Nyquist.IQ is intended | |||
| solely to be integrated only with | |||
| Omega Medical Imaging CS- | |||
| series-FP systems.) | |||
| Classification | |||
| Name: | Image-intensified | ||
| Fluoroscopic X-ray system | Image-intensified Fluoroscopic | ||
| X-ray system | Image-intensified Fluoroscopic | ||
| X-ray system | |||
| CFR | |||
| Regulation #: | 892.1650 | 892.1650 | 892.1650 |
| Device Class | Class II | Class II | Class II |
| Classification | |||
| Product Code: | JAA, OWB | JAA, OWB | JAA, MQB |
PRODUCT OVERVIEW
Substantial Equivalence:
Detailed in the Bench testing section of this submission.
Safety information:
- ∑ The Omega Nyquist.IQ Image Processor complies with the applicable requirements of 21 CFR 820.
- ∑ The Omega Nyquist.IQ Image Processor complies with the international safety standards EN 60601-1, IEC 60601-1-2, EN ISO 15223-1 and EN ISO 14971.
- 2 The Omega Nyquist.IQ Image Processor system comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90.
- ∑ The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with applicable parts of the IEC60601-1 standards and its collateral standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020, that apply to this device will be met and reported in this initial report.
8
Safety is assured through a risk management process and manufacturing is in compliance with the Quality System Regulations.
Referenced Guidance Documents:
- ∑ Guidance for this submission of 510(k) for Indications of use as provided in: Pediatric Information for X-rav Imaging Device Premarket Notifications (Document issued on November 28º, 2017) Guidance for Industry and Food and Drug Administration Staff.
- 2 Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. (Document issued on October 2018)
-
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Document issued on May 11, 2005)
- S Guidance for Industry and FDA Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-powered Medical Devices. (Document issued on July11, 2016)
- S Guidance for this submission of 510(k) for (SSXID) Solid State X-ray Imaging Devices issued on: September 1, 2016 was used to establish substantial equivalence
- S Guidance for industry and FDA Staff User Fees and Refunds for Premarket Notifications 510(k)s, (Document issued on October 2, 2017)
-
Guidance for industry and FDA Staff Refuse to Accept Policy for 510(k) (Document issued on September 2019)
- ∑ Guidance for industry and FDA Staff -Format for Traditional and Abbreviated 510(k)s (Document issued on September 2019)
-
Guidance for industry and FDA Staff Deciding when to submit a 510(k) for a change to an existing device. (Document issued on October 25, 2017)
- 2 Guidance for industry and FDA Staff The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (Document Issued on July 28, 2014)
-
Guidance for industry and FDA Staff Guidance for Off-The-Shelf Software Use in Medical Devices (Document issued on September 2019)
-
Guidance for industry and FDA Staff Guidance for the Content of Premarket Submission for Software in Medical Devices. (Document issued May 11th, 2005)
- S Guidance for industry and Food and Drug Administration Staff Policy Clarification for Certain Fluoroscopic Equipment Requirements (Document issued on May 8, 2019)
- S Guidance for Industry and FDA Staff Medical X-Ray Imaging Devices Conformance with IEC Standards. (Document issued on May 8,2019)
-
Guidance for Industry and FDA Staff Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment. (Document issued on December 17, 2018)
-
Guidance for Industry and FDA Staff Guidance for the submission of 510(k)s for Solid state X-ray Imaging Devices. (Document issued on September 1, 2016)