Description
This guidance document provides FDA’s recommendations regarding premarket notification (510(k)) submissions for display devices intended for use in diagnostic radiology. This guidance applies to display devices intended for diagnostic radiology as identified by their classification regulation (21 CFR 892.2050) and product codes. This includes display devices for diagnostic radiology that may be referred to as soft-copy display or medical grade monitors. The recommendations are intended to promote consistency and facilitate efficient review of display devices.
Scope & Applicability
Product Classes
2The primary subject of the guidance, categorized as requiring Basic Documentation Level.; Subject of the guidance document; The primary subject of the guidance document regarding modifications and submissions.
Specific category of display device with rigorous testing requirements
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
4Level of documentation required based on risk; documentation threshold for software functions; Risk-based documentation category; Outcome for software functions with low risk of death or serious injury
Former risk classification for display devices under the superseded guidance.
Standard for 510(k) clearance
Categorization (minor, moderate, major) for software risk.
Related CFR Sections (8)
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR892.2050§ 892.2050 Medical image management and processing system.
(a) Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management.Read full regulation →
- 21CFR892.1650§ 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, patiRead full regulation →
- 21CFR892.1550§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a) Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces oRead full regulation →
- 21CFR892.2040§ 892.2040 Medical image hardcopy device.
(a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.Read full regulation →
- 21CFR870.2450§ 870.2450 Medical cathode-ray tube display.
(a) Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.Read full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
Related Warning Letters (10)
- 2025-06-24
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
- 2024-11-08
CGMP/QSR/Medical Devices/Adulterated
Rolence Ent. Inc.
- 2024-09-10
CGMP/QSR/Medical Devices/Adulterated
Optikem International, Inc.
- 2024-01-09
CGMP/QSR/Medical Devices/Adulterated
Deymed Diagnostic s.r.o.
- 2023-11-14
CGMP/QSR/Medical Devices/Misbranded
Wello Inc.
- 2023-06-20
CGMP/QSR/Medical Devices/Adulterated
Vitang Technology LLC
- 2023-06-06
Medical Devices/Adulterated/Quality System Regulation (QSR)
iRhythm Technologies, Inc.
- 2023-04-25
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Medivance Instruments Ltd.
- 2023-04-19
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Abbott Point of Care Canada Limited
- 2023-04-18
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
North American Diagnostics, LLC
See Also (8)
- Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)
- General/Specific Intended Use - Guidance for Industry (Status: Final)
- Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff (Status: Final)
- Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (Status: Final)
- Medical Glove Guidance Manual: Guidance for Industry and FDA Staff (Status: Final)