FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTEGRA IMMOBILIZATION SYSTEM
K Number: K050888
·
Decision May 23, 2005
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
10
Review Days
46
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
- INTEGRA IMMOBILIZATION SYSTEM
- K Number
- K050888
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diacor, Inc.
- Date Received
- April 7, 2005
- Decision Date
- May 23, 2005
- 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 Diacor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K121929 | ZEPHYR 'X-SERIES PATIENT TRANSFER SLED | Jan 17, 2013 | Substantially Equivalent |
| K954414 | CENTRALITE BACKPOINTER | Oct 23, 1995 | Substantially Equivalent |
| K953046 | PERI-PUSHER | Sep 22, 1995 | Substantially Equivalent |
| K950112 | CENTRALITE(R)-DLL SERIES | Aug 16, 1995 | Substantially Equivalent |
| K934566 | RADASSIST | Nov 3, 1993 | Substantially Equivalent |
| K930246 | MAMMORX | Jul 26, 1993 | Substantially Equivalent |
| K893398 | CENTRALITE BACKPOINTER | Aug 17, 1989 | Substantially Equivalent |
| K872489 | CENTRALITE | Jul 15, 1987 | Substantially Equivalent |
| K860193 | PORTALCAST | Jan 30, 1986 | Substantially Equivalent |