Device, Sensing, Optical Contour
An optical contour sensing device is a system that uses optical measurement techniques to detect or map the surface contour or shape of a body part or object, potentially for use in prosthetics fitting, orthopedic assessment, or physical medicine applications. This device is currently unclassified by the FDA, with no assigned regulation number or medical specialty, meaning its regulatory classification has not been finalized. The product code is LDK. No special risk flags apply.
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Basic Information
- Product Code
- LDK
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- PM
- Submission Type
- 7
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K230463 | NSite Scoliosis Assessment App | Nov 15, 2023 | Substantially Equivalent | Nsite, Inc. |
| K232023 | Momentum Spine | Oct 04, 2023 | Substantially Equivalent | Momentum Health, Inc. |
| K183485 | CryoVizion System | Aug 28, 2019 | Substantially Equivalent | Cryos Technologies, Inc. |
| K923792 | QUANTEC SPINAL MEASUEMENT SYSTEM | Apr 20, 1994 | Substantially Equivalent | Quantec Image Processing , Ltd. |
| K860225 | METRICOM | Feb 11, 1986 | Substantially Equivalent | Far Orthopedics, Inc. |
| K851133 | TERRAN BIOMECHANICAL ANALYSIS SYSTEM | Jun 19, 1985 | Substantially Equivalent | Terran Biomedical Instruments |
| K844736 | ISIS | Mar 21, 1985 | Substantially Equivalent | Oxford Medilog, Inc. |
| K800591 | CONTOUROGRAPH M-500 | Apr 02, 1980 | Substantially Equivalent | Bio-Tek Instruments, 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.