FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTRACRANIAL RADIOTHERAPY SYSTEM
K Number: K982463
·
Decision Sep 30, 1998
Classifications
1
FEI Numbers
123
Registration Numbers
124
Same Product Code
717
Applicant Total
36
Review Days
77
Basic Information
- Device Name
- EXTRACRANIAL RADIOTHERAPY SYSTEM
- K Number
- K982463
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HOWMEDICA, INC.
- Date Received
- July 15, 1998
- Decision Date
- September 30, 1998
- 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 |
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Other Clearances by HOWMEDICA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K984251 | XIA SPINE SYSTEM | Feb 24, 1999 | Substantially Equivalent |
| K984202 | HOWMEDICA HUMERAL INTERCALARY SYSTEM | Feb 5, 1999 | Substantially Equivalent |
| K984305 | ZETA MULTIZONE LOCKING NAIL SYSTEM | Feb 1, 1999 | Substantially Equivalent |
| K983885 | BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES | Jan 29, 1999 | Substantially Equivalent |
| K983358 | G/K SFN AND STN LOCKING NAILS | Nov 18, 1998 | Substantially Equivalent |
| K982248 | HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A | Aug 31, 1998 | Substantially Equivalent |
| K980813 | RELIANCE LONG STEM FEMORAL COMPONENTS | Jun 26, 1998 | Substantially Equivalent |
| K981283 | ROGACHEFSKY DISTAL RADIUS PLATES | Jun 10, 1998 | Substantially Equivalent |
| K980843 | EXETER INTRAMEDULLARY BONE PLUG | Jun 2, 1998 | Substantially Equivalent |
| K980239 | PARTNERSHIP CALCAR FEMORAL COMPONENTS | Apr 16, 1998 | Substantially Equivalent |