510(k) K923792
- Device
- QUANTEC SPINAL MEASUEMENT SYSTEM
- Applicant
- QUANTEC IMAGE PROCESSING LTD.
- 510(k) number
- K923792
- Product code
- LDK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-04-20
- Date received
- 1992-07-28
- Regulation
- 510(k) Premarket Notification
- Classification name
- Device, Sensing, Optical Contour
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Physical Medicine
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRUCE D GROVES
- Address
- 37 King Rd. Madison NJ US 07940 07940
FDA Registration Numbers#
- 3029900922
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LDK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230463 | NSite Scoliosis Assessment App | Nsite, Inc. | 2023-11-15 |
| K232023 | Momentum Spine | Momentum Health, Inc. | 2023-10-04 |
| K183485 | CryoVizion System | Cryos Technologies, Inc. | 2019-08-28 |
| K860225 | METRICOM | Far Orthopedics, Inc. | 1986-02-11 |
| K851133 | TERRAN BIOMECHANICAL ANALYSIS SYSTEM | Terran Biomedical Instruments | 1985-06-19 |
| K844736 | ISIS | Oxford Medilog, Inc. | 1985-03-21 |
| K800591 | CONTOUROGRAPH M-500 | Bio-Tek Instruments, Inc. | 1980-04-02 |
Legacy Summary#
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FDA Review#
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