Computer, Diagnostic, Programmable

FDA product classification. Device class 2. Review panel CV.

Classification

Each row is one field of the openFDA record. The grey name is the field’s name in openFDA’s documentation.

Field	Value	Field name
Product code	DQK	product_code
Device name	Computer, Diagnostic, Programmable	device_name
Device class	2	device_class
Review panel	CV	review_panel
Regulation number	870.1425	regulation_number
Medical specialty	Cardiovascular	medical_specialty

Source: FDA openFDA, device/classification, product code DQK, as held in ArrHub’s controlled vocabulary with its citation. Public domain (CC0).

PMA records with this code

Every verified record ArrHub holds under the code, newest first.

None in the verified view.

510(k) clearances with this code

Every verified record ArrHub holds under the code, newest first.

Decision	Applicant	Device	Record
2025-12-11	Medicalgorithmics S.A.	DeepRhythmAI	K253141 FDA
2025-12-04	Vektor Medical, Inc.	Vektor Computational ECG Mapping System (vMap®)	K252429 FDA

ArrHub

What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.

ArrHub vocabulary

Electrophysiology

DQK is one of the 56 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 13 October 2026.

Raw record

The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.

Show the raw record (JSON)device/classification.json?search=product_code:DQK

{
  "id": "fda_product_code:DQK",
  "vocabulary": "fda_product_code",
  "term": "DQK",
  "definition": "Computer, Diagnostic, Programmable",
  "attrs": {
    "device_class": "2",
    "review_panel": "CV",
    "medical_specialty": "Cardiovascular",
    "regulation_number": "870.1425"
  },
  "jurisdiction": "US",
  "authority": "FDA",
  "ep_relevant": true,
  "source_url": "https://api.fda.gov/device/classification.json?search=product_code:DQK",
  "verified_by": "Bruno Deslauriers",
  "verified_at": "2026-10-13T20:58:29.667854+00:00",
  "notes": "Fetched from https://open.fda.gov/apis/device/classification/ Included 2026-10-13 by the editor's decision (PR #39) for the mapping and navigation category. DQK is a general code: VERIFICATION.md lists generic diagnostic computers under DQK among the membership traps. At inclusion the registry held two DQK 510(k)s, K252429 and K253141.",
  "created_at": "2026-09-20T01:19:34.130262+00:00",
  "updated_at": "2026-10-13T20:58:29.667854+00:00"
}

The readable page is rendered from the record held in ArrHub’s verified view; the agency record at api.fda.gov governs where they differ.

Links open the agency’s own records. Unlabelled links open web pages. Links marked (JSON) open an agency’s data record, which a browser shows as plain text.

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