FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1)
K Number: K934523
·
Decision Feb 8, 1995
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
56
Review Days
509
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1)
- K Number
- K934523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radionics, Inc.
- Date Received
- September 17, 1993
- Decision Date
- February 8, 1995
- Product Code
- IYE
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYE), ordered by most recent decision date.
ThinkQA 3
FDA 510(k)
FDA Class 2
·Radiology
LUNA 3D
FDA 510(k)
FDA Class 2
·Radiology
AerFrame Patient Immobilization System (AFPIS)
FDA 510(k)
FDA Class 2
·Radiology
VERIQA RT EPID 3D
FDA 510(k)
FDA Class 2
·Radiology
ClearCheck (RADCC V2.7)
FDA 510(k)
FDA Class 2
·Radiology
AlignRT Plus (8.0)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Radionics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030697 | RADIONICS SINGLE USE GROUND PAD (DGP-HP) | Apr 4, 2003 | Substantially Equivalent |
| K001741 | RADIONICS RF DISC CATHETER ELECTRODE SYSTEM | Oct 23, 2000 | Substantially Equivalent |
| K002773 | NEUROMAP WITH NEURO 100 | Oct 23, 2000 | Substantially Equivalent |
| K992226 | XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | Aug 4, 2000 | Substantially Equivalent |
| K001950 | OPTICAL TRACKING SYSTEM (OTS) | Jul 26, 2000 | Substantially Equivalent |
| K001700 | XPLAN 2.1 | Jun 28, 2000 | Substantially Equivalent |
| K001431 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | May 17, 2000 | Substantially Equivalent |
| K000057 | RADIONICS LUMBOPERITONEAL SHUNT | Mar 20, 2000 | Substantially Equivalent |
| K993594 | CONFORMAX MMLC VR1 | Dec 15, 1999 | Substantially Equivalent |
| K991399 | RADIONICS MICROELECTRODE KIT | Sep 21, 1999 | Substantially Equivalent |