Imaging Dynamics Company , Ltd.: FDA filings under this applicant name

FDA lists 20 510(k) clearances under 2 spellings of the applicant name “Imaging Dynamics Company , Ltd.” (first 2004, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 28 days. Since 2017 the median was 98 days, against 41 days for all cleared 510(k)s in the same product codes. 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Imaging Dynamics Company , Ltd. took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 41 days.

Top product codes

Review panels

• Radiology (20)

Most recent Imaging Dynamics Company , Ltd. 510(k) clearances

10 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Imaging Dynamics Company , Ltd..

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.

FDA spellings included

FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• Imaging Dynamics Company , Ltd. (19)
• Imaging Dynamics Company Limited (1)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Imaging Sciences Intl., Inc. (7 510(k)s)
• Imaging Biometrics, LLC (4 510(k)s)
• Imaging Engineering, LLC (4 510(k)s)
• Imaging Accessories, Inc. (2 510(k)s)
• Imaging Sciences International (2 510(k)s)
• Imaging Services, Inc. (2 510(k)s)
• Imaging Therapeutics, Inc. (2 510(k)s)
• Imaging and X-Ray Intl., Inc. (1 510(k)s)
• Imaging Concepts, Inc. (1 510(k)s)
• Imaging Dynamics Corp. (1 510(k)s)
• Imaging Sciences International (Dba Gendex, LLC) (1 510(k)s)
• Imaging Sciences International /Gendex/Dexis (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Imaging Dynamics Company , Ltd.?

FDA lists 20 510(k) clearances under 2 spellings of the applicant name “Imaging Dynamics Company , Ltd.” (first 2004, latest 2017), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Imaging Dynamics Company , Ltd.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Imaging Dynamics Company , Ltd. is 28 days. Since 2017: 98 days, versus 41 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Imaging Dynamics Company , Ltd.?

The most frequent FDA product codes under this applicant name are KPR (System, X-Ray, Stationary, 11); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 9).

Next steps

• See all 20 Imaging Dynamics Company , Ltd. clearances with predicates and recalls
• Run predicate analysis for product code KPR, Imaging Dynamics Company , Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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