Afp Imaging Corp.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Afp Imaging Corp.” (first 1985, latest 2012), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 51 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | 3 | 3 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| EAP | Unit, X-Ray, Intraoral | 1 | 1 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| IXW | Processor, Radiographic-Film, Automatic | 1 | 1 |
| IXY | Holder, Radiographic Cassette, Wall-Mounted | 1 | 1 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| LMA | Digitizer, Image, Radiological | 1 | 1 |
| LMC | Camera, Multi Format, Radiological | 1 | 1 |
Review panels
Most recent Afp Imaging Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123419 | EVA SELECT DIGITAL DENTAL IMAGING SYSTEM | MUH | 2012-12-27 | 51 |
| K072357 | NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM | MUH | 2007-09-18 | 27 |
| K041120 | EV APAN DIGITAL, MODEL K1VSM2000 | MUH | 2004-08-30 | 123 |
| K030647 | EVA DIGITAL DENTAL X-RAY SYSTEM | EHD | 2003-03-20 | 20 |
| K014144 | EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 | EBF | 2002-02-07 | 51 |
| K013176 | MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE | EHD | 2001-10-16 | 22 |
| K974619 | SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM | LMA | 1998-02-25 | 76 |
| K950288 | AUTOLASER MULTI FORMAT CAMERA | LMC | 1995-04-04 | 69 |
| K925885 | AFP 17 X 4 AUTOMATIC FILM PROCESSOR | IXW | 1993-06-09 | 205 |
| K930761 | IMAGE-X 70 INTRAORAL X-RAY SYSTEM | EAP | 1993-05-25 | 102 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Afp Imaging Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Afp Imaging Corp.?
FDA lists 13 510(k) clearances under the applicant name “Afp Imaging Corp.” (first 1985, latest 2012), across 10 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Afp Imaging Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Afp Imaging Corp. is 76 days.
Which FDA product codes appear under Afp Imaging Corp.?
The most frequent FDA product codes under this applicant name are MUH (System, X-Ray, Extraoral Source, Digital, 3); EHD (Unit, X-Ray, Extraoral With Timer, 2); EAP (Unit, X-Ray, Intraoral, 1).
Next steps
- See all 13 Afp Imaging Corp. clearances with predicates and recalls
- Run predicate analysis for product code MUH, Afp Imaging Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.