Product Code: SHN
FDA class 1
21 CFR 892.1940
Calibration Software For Radiology Displays
Radiology
510(k)s
1
FEI Numbers
1
Registration Numbers
1
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- SHN
- Device Class
- FDA class 1
- Regulation Number
- 892.1940
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253582 | Medical Imaging Calibration Feature (MICF) | Apr 01, 2026 | Substantially Equivalent | Apple, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.