FDA.reportPublic FDA data

Medical Imaging Calibration Feature (MICF)

Primary DI
00195950591552
Brand
Medical Imaging Calibration Feature (MICF)
Company
APPLE INC.
Model
Feature version 1.X
Device description
Medical Imaging Calibration Feature Display Firmware (1.X)
Published
2026-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SHNCalibration Software For Radiology Displays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SHNCalibration Software For Radiology DisplaysRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253582000Medical Imaging Calibration Feature (MICF)Apple, Inc.2026-04-01SHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195950591552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195950591552001959505915521959505915520195950591552

GMDN Terms#

Term, Definition table
TermDefinition
Radiology workstation display quality assurance softwareA software application intended to be used to measure, calibrate, and adjust the display parameters of a radiology workstation monitor to standardize the quality level of digital radiological images (DICOM images) displayed by the monitor. It is typically used to manage the display quality of several computers within a healthcare facility, and to feed data (e.g., alerts) back to a central user(s). It is not intended for image processing, distribution, or viewing.

Regulatory Flags#

DUNS number
060704780
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195950591545Medical Imaging Calibration Feature (MICF)Feature version 1.X2026-04-23
00190199649286ECG 2.0 AppFeature Version 2.x2020-12-15
00190199649293ECG 2.0 AppFeature Version 2.x2020-12-15
00190198909534ECG AppFeature Version 1.x2019-01-14
00190198909541ECG AppFeature Version 1.x2019-01-14
00195949001789Hypertension Notification Feature (HTNF)Feature version 1.X2025-09-18
00195949001796Hypertension Notification Feature (HTNF)Feature version 1.X2025-09-18
00195949948411Digital Prism Correction Feature (DPCF)Feature version 1.X2025-09-11
00195950732382Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195950732399Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195950732405Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195950732412Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195949149931Hearing Aid Feature (HAF)Feature version 1.X2024-10-21
00194253312512Cycle Tracking 4.0Feature Version 4.x2024-11-01
00194253312529Cycle Tracking 4.0Feature Version 4.x2024-11-01
00195949149924Hearing Aid Feature (HAF)Feature version 1.X2024-10-21
00195949149948Hearing Test Feature (HTF)Feature version 1.X2024-10-21
00195949149955Hearing Test Feature (HTF)Feature version 1.X2024-10-21
00195950095067Hearing Aid Feature (HAF)Feature version 1.X2024-10-21
00195950095074Hearing Aid Feature (HAF)Feature version 1.X2024-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195950591545Medical Imaging Calibration Feature (MICF)APPLE INC.SHN2026-04-23