FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM
K Number: K925705
·
Decision Dec 28, 1992
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
9
Applicant Total
5
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
- ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM
- K Number
- K925705
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1920
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Denar Corp.
- Date Received
- November 12, 1992
- Decision Date
- December 28, 1992
- Product Code
- IWY
- 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 |
|---|---|---|---|
| IWY | Holder, Head, Radiographic | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IWY), ordered by most recent decision date.
HEAD HOLDING DEVICE/SLEEP APNEA
FDA 510(k)
FDA Class 1
·Radiology
MTD HEDREST
FDA 510(k)
FDA Class 1
·Radiology
DUOCEPH
FDA 510(k)
FDA Class 1
·Radiology
KELLER CEPHALOMETRIC DEVICE
FDA 510(k)
FDA Class 1
·Radiology
HEAD-SPINE STABILIZER HSS-1
FDA 510(k)
FDA Class 1
·Radiology
PORTA-STAT
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Denar Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K924759 | COLLIMATOR LIGHT SOURCE | Dec 9, 1992 | Substantially Equivalent |
| K884845 | STERI-OSS | Feb 10, 1989 | Substantially Equivalent |
| K883373 | STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT | Jan 13, 1989 | Substantially Equivalent |
| K852802 | DENAR DENTAL IMPLANT | Sep 23, 1985 | Substantially Equivalent |