Anholt Technologies Inc.
Avondale, PA, US
Anholt Technologies Inc. appears in FDA device records in Avondale, PA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Anholt Technologies Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Wfr/Aquaplast Corp.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 8 510(k) clearances for Anholt Technologies Inc. between 1994 and 2012. The busiest year on record is 1994, with 3. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 1997 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2006 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120916 | QFIX RADIOTHERAPY CHAIR | JAI | Substantially Equivalent | |
| K060671 | KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS | JAI | Substantially Equivalent | |
| K032156 | ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT | IYE | Substantially Equivalent | |
| K021124 | ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER | IYE | Substantially Equivalent | |
| K973370 | AQUAPLAST PALATAL STENT | EMA | Substantially Equivalent | |
| K943871 | AQUAPLAST TIE DOWN DRESSING | LZM | Substantially Equivalent | |
| K942158 | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS | EPP | Substantially Equivalent | |
| K935067 | AQUAPLAST | IYE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2247992 | 1000208827 | Anholt Technologies Inc. | 440 CHURCH ROAD, Avondale, PA 19311 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- EMACement, Dental
- JAICouch, Radiation Therapy, Powered
- FRZDevice, Patient Transfer, Powered
- LZMGuard, Skin Graft
- IWYHolder, Head, Radiographic
- LHOInstrument, Quality-Assurance, Radiologic
- OWBInterventional Fluoroscopic X-Ray System
- FSALift, Patient, Non-Ac-Powered
- FZZMarker, Skin
- IXGPhantom, Anthropomorphic, Radiographic
- KPYShield, Protective, Personnel
- EPPSplint, Nasal
- LNHSystem, Nuclear Magnetic Resonance Imaging
- LHNSystem, Radiation Therapy, Charged-Particle, Medical
- KPSSystem, Tomography, Computed, Emission
- IZISystem, X-Ray, Angiographic
- JAKSystem, X-Ray, Tomography, Computed
- GDCTable, Operating-Room, Electrical
- IXQTable, Radiographic, Stationary Top
- KXJTable, Radiologic
- OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1264-2016 | Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy. It may be used with CT and MR scanners to acquire images for radiation therapy planning. | Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the zero reference with respect to other Access ClearVue Prone Breast devices. This can result in differences in scale orientation. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain